MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 5 VR-T DX DF4 PROMRI; ICD

Model Number	429564
Medical Device Problem Codes	Pacemaker Found in Back-Up Mode (1440); Failure to Transmit Record (1521)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 the icd stopped transmitting to home monitoring.We tested all the possibilities and changed the cardio messenger of the patient.On (b)(6), follow up was not successful.Device in backup mode, unable to be reinitialized.Device was explanted and returned, but an explant date was not provided.
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.Therefore, the device was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.The measurement of the battery voltage showed a depleted battery.The current consumption of the electronic module was directly measured and found to be elevated.Further electrical investigations revealed that a capacitor of the electronic module was damaged, causing an increased current consumption, draining the battery.In conclusion, analysis revealed a damaged capacitor on the electronic module.There was no sign of any inconsistency during the manufacturing process which may be related to this observation.It is therefore assumed that the damage occurred after the device shipment, however, the date of occurrence was not determinable.

• Brand Name: RIVACOR 5 VR-T DX DF4 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12238719
• Report Number: 1028232-2021-04223
• Device Sequence Number: 3900829
• Product Code: NIK
• UDI-Device Identifier: 04035479156909
• UDI-Public: 04035479156909
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 02/28/2022
• Device Model Number: 429564
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 11/01/2021
• 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