Medtronic Neuromodulation
Minneapolis, MN, US
MEDTRONIC NEUROMODULATION appears in FDA device records in Minneapolis, MN. FDA records list 3 510(k) clearances between and , 1,418 PMA records and one registered establishment. As of , FDA records show 194 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Medtronic Neuromodulation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Medtronic Inc, Neurological & Spinal Divisionrecall
- Medtronic Neurological510(k), recall
- Medtronic, Inc. - Neuromodulationrecall
510(k) clearance history
FDA records hold 3 510(k) clearances for Medtronic Neuromodulation between 2001 and 2021. The busiest year on record is 2001, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2003 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| DEN210003 | SureTune4 Software | QQC | Unknown | |
| K033016 | PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892 | GZB | Substantially Equivalent | |
| K013063 | GRIP LOCK ANCHOR, MODEL 411374 | GZB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2182207 | 2182207 | MEDTRONIC NEUROMODULATION | 7000 Central Ave., N.E., Minneapolis, MN 55432 US | 2026 | and 16 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QQCBrain Stimulation Programming Planning Software.
- GXRCover, Burr Hole
- SGSDeep Brain Stimulation For The Treatment Of Dystonia
- OLMDeep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)
- GDIDissector, Surgical, General & Plastic Surgery
- OAGGarment, Storage, Peritoneal Dialysis Catheter
- HBLHolder, Head, Neurosurgical (Skull Clamp)
- QONImplanted Electrical Device Intended For Treatment Of Fecal Incontinence
- MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)
- HAOInstrument, Surgical, Non-Powered
- LNQIntestinal Stimulator
- OUGMedical Device Data System
- LKKPump, Infusion, Implanted, Programmable
- MFRStimulator, Brain, Implanted, For Behavior Modification
- EZWStimulator, Electrical, Implantable, For Incontinence
- PJSStimulator, Electrical, Implanted, For Essential Tremor
- NHLStimulator, Electrical, Implanted, For Parkinsonian Symptoms
- MHYStimulator, Electrical, Implanted, For Parkinsonian Tremor
- GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)
- NAMStimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)
- LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief
- QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy
- MBXStimulator, Thalamic, Epilepsy, Implanted
- QPTStimulator, Tibial, Electrical, Implantable, For Urinary Incontinence
- KGXTape And Bandage, Adhesive
Recall records
Showing 25 of 194| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2241-2026 | Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. | Class II | Open, Classified | |
| Z-2240-2026 | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. | Class II | Open, Classified | |
| Z-2201-2026 | Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all. | Class II | Open, Classified | |
| Z-1043-2026 | A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900). | Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure. | Class II | Open, Classified | |
| Z-0996-2026 | Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG | Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS. | Class II | Open, Classified | |
| Z-1704-2025 | Enhanced Verify Evaluation Handset (CFN HH90130FA) | Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period. | Class II | Open, Classified | |
| Z-1543-2025 | Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators | There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used. | Class II | Open, Classified | |
| Z-1506-2025 | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System. | Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. | Class II | Open, Classified | |
| Z-0774-2025 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E | Software issues were identified in application version 2.x. | Class II | Open, Classified | |
| Z-0773-2025 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D | Software issues were identified in application version 2.x. | Class II | Open, Classified | |
| Z-0772-2025 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C | Software issues were identified in application version 2.x. | Class II | Open, Classified | |
| Z-0771-2025 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B | Software issues were identified in application version 2.x. | Class II | Open, Classified | |
| Z-0206-2025 | Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. | A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear. | Class II | Open, Classified | |
| Z-0372-2025 | Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Brain Stimulation (DBS) system. WR9220A is used with InterStim Micro, Model 97810, as part of Pelvic Health system | The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. | Class II | Open, Classified | |
| Z-0137-2025 | SynchroMed II Infusion Pump. Product Number: 8637-20 | Potential for error and inability to interrogate pump due to data corruption in the pump memory. | Class II | Open, Classified | |
| Z-0132-2025 | Vanta Implantable Neurostimulator (INS), Model 977006 | Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements. | Class II | Open, Classified | |
| Z-3073-2024 | Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator. | A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup. | Class II | Open, Classified | |
| Z-2427-2024 | A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neurostimulator, 4. INS 37603 Activa SCx Neurostimulator, 5. INS B35200 DBS PERCEPT PC, 6. INS B35300 PERCEPT RC V1 | Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility. | Class II | Open, Classified | |
| Z-2352-2024 | Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit) | Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion. | Class II | Open, Classified | |
| Z-1691-2024 | Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator | inability to reprogram one device | Class II | Open, Classified | |
| Z-0780-2024 | Model A710 Intellis Clinician Programmer Application, version 2.0.97 | Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief. | Class II | Open, Classified | |
| Z-0615-2024 | Medtronic SynchroMed II, Model 8637-40, Programmable pump | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling. | Class II | Open, Classified | |
| Z-0614-2024 | Medtronic SynchroMed II, Model 8637-20, Programmable pump | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling. | Class II | Open, Classified | |
| Z-0354-2024 | Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators | Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language. | Class II | Open, Classified | |
| Z-2365-2023 | Medtronic InterStim Ground Pad REF 041826 | Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain