MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 5 DR-T DF4 PROMRI

Model Number 429563

Device Problem Failure to Interrogate (1332)

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

Event Date 09/30/2020

Event Type  malfunction  

Event Description

After an implantation period of approx.3 months, it was reported that the icd was not interrogable.The device was explanted.

Manufacturer Narrative

The icd was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned device data.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process which might be related to the clinical observation.The returned device data from 13-jul-2020 have been analyzed.The analysis did not show any anomalies.Based on the information available for analysis, the root cause of the clinical observation was not determinable.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned device data revealed no indication of a device malfunction.

• Brand Name: RIVACOR 5 DR-T DF4 PROMRI
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10638248
• MDR Text Key: 210151625
• Report Number: 1028232-2020-04295
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 04035479156893
• UDI-Public: 04035479156893
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 429563
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization