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

Model Number 429564

Device Problems Pacemaker Found in Back-Up Mode (1440); Failure to Transmit Record (1521)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12238719
• MDR Text Key: 263835077
• Report Number: 1028232-2021-04223
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479156909
• UDI-Public: 04035479156909
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization