MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILIVIA NEO 7 VR-T DF-1 PROMRI; ICD

Model Number	429531
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was prophylactically explanted and replaced due to the field safety corrective action, bio-lqc.The icd was implanted and active for approx.10 months.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in march 2021.
Additional Manufacturer Narrative
The icd was received for analysis and inspected.Upon receipt the device was interrogated.The interrogation could be properly performed and revealed the bos battery status.All electrical parameters were verified and showed a normal device behavior.Especially, the current consumption and the battery state of discharge were found normal and as expected.There was no indication of a device malfunction.

• Brand Name: ILIVIA NEO 7 VR-T DF-1 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12158382
• Report Number: 1028232-2021-03897
• Device Sequence Number: 14395027
• Product Code: LWS
• UDI-Device Identifier: 04035479156763
• UDI-Public: 04035479156763
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 429531
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization