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

Model Number	429530
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was explanted approx.5 months after the implantation due to eri status.This icd is affected by a field safety corrective action, bio-lqc, initiated in march 2021.
Additional Manufacturer Narrative
Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.Next, the icd was subjected to an electrical analysis, revealing that the device could not be interrogated.In order to obtain further insights, the icd was opened and the electronic module was subjected to an electrical analysis.The measurement of the battery voltage revealed a depleted battery.The overall current consumption of the electronic module was measured and found to be elevated.During further electrical investigations a low voltage capacitor of the electronic module was found damaged.This damaged low voltage capacitor led to an increased current consumption of the electronic module and can therefore be considered as the root cause of the clinical observation.Based on the damage symptoms, the damage resulted from an internal short whose origin could not be conclusively determined.In accordance to biotroniks post-market surveillance system this event represents a singular event.Up to date biotronik is not aware of any other similar event worldwide.

• Brand Name: ILIVIA NEO 7 VR-T DX DF-1 PROMRI
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11741643
• Report Number: 1028232-2021-02178
• Device Sequence Number: 14431002
• Product Code: LWS
• UDI-Device Identifier: 04035479156756
• UDI-Public: 04035479156756
• Combination Product (Y/N): N
• 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): 03/29/2021

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: 12/31/2020
• Device Model Number: 429530
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1