Z-1463-2021Class II
BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 -
BIOTRONIK AG / initiated 2021-03-08 / Terminated / root cause: design
BIOTRONIK Inc began a recall of BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular... on . FDA classified it as Class II and gives the reason as "There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1463-2021
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- BIOTRONIK AG
- Product
- BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Product code
- LWS Implantable Cardioverter Defibrillator (Non-Crt)
- Reason for recall
- There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- On 3/8/21, BIOTRONIK issued a "Urgent Field Safety" recall notification to all affected consignees via UPS. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. To determine if a specific device is affected by this corrective action you can lookup the device at the following web address: www.biotronik.com/devicelookup. 2. Devices in stock: Do not implant any potentially affected devices. Local BIOTRONIK representatives will replace affected devices in hospital inventory. 3. Continue with the standard patient follow-up schedule. -During follow-ups: Verify the status of the device and battery during in-office or Home Monitoring follow-ups. Please note that unresponsive devicesor those that are not transmitting data may be experiencing this issue and your BIOTRONIK representative should be informed if you observe any unusual device behavior. -Home Monitoring should be utilized whenever possible as it provides timely ERI warnings to reduce the risk of sudden loss of therapy. If you do not yet use Home Monitoring, please consider if this option is appropriate for you and your patients. BIOTRONIK will provide Cardio Messenger devices to monitor implants affected by this advisory. If you would like to register for Home Monitoring, please contact your local BIOTRONIK representative. 4. If there is an unexpected ERI notification for a device that is subject to this advisory, a timely replacement should be considered based on the patients underlying conditions: - For patients that are not pacemaker dependent, or patients with a primary prevention ICD, device replacement within one week after ERI notification is recommended. - For pacemaker dependent patients, replacement of the device is recommended immediately after ERI notification. 5. In consultation with our medical advisory board, BIOTRONIK does not recommend prophylactic replacement. The risk of complications for ICD exchange1-3 outweighs
- Quantity in commerce
- 17 UNITS
- Distribution
- US: Nationwide OUS: Worldwide
- Product codes and lots
- Serial Number 84736231 84737026 84737315 84737560 84738576 84744864 84744872 84745476 84748008 84748843 84749243 84749246 84751394 84751632 84753554 84755167 84761228
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1441-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1442-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1443-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1444-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1445-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1446-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1447-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1448-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1449-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1450-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1451-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1452-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1453-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1454-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1455-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1456-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1457-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1458-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1459-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1460-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1461-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1462-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1463-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1464-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1465-2021 | Class II | Terminated | Voluntary: Firm initiated |
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