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

Model Number 429564

Device Problem Premature End-of-Life Indicator (1480)

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

Event Date 04/05/2024

Event Type  malfunction  

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 reviewed.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test proved the icd functions to be as specified.The returned device data have been analyzed.Analysis revealed that the icd did not activate the eri battery status, as mentioned in the complaint.Instead, the icd activated the battery status eos.The activation of the eos battery status resulted from a large amount of successive charging cycles with shock deliveries within a short period of time.A number of 40 charging cycles was performed by the device within 25 minutes on april 3rd, 2024.As indicated by the available iegms, all shocks were appropriately delivered.Only intrinsic heart signals led to a vf storm.The battery status eos was successfully reset.Analysis of the data after reset revealed a normal and expected functioning of the icd.The battery status is bos.The analysis did not show any anomalies.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.

Event Description

It was reported that the device showed eos status.The device reset was successful and it remains implanted.Should additional information be received, this file will be updated.

• Brand Name: RIVACOR 5 VR-T DX DF4 PROMRI
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 19089245
• MDR Text Key: 340368992
• Report Number: 1028232-2024-01990
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 429564
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1