MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 7 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number 429532

Device Problem Pacemaker Found in Back-Up Mode (1440)

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

Event Date 01/05/2024

Event Type  malfunction  

Event Description

This device was reported to repeatedly go into back up, even after being reinitialized.Explant has been recommended due to this unexpected behavior.Device remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.

Manufacturer Narrative

The device 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 data was inspected.The inspection revealed that the icd activated the safety backup mode, because it detected invalid memory content during the automatic signature check.In general, the icd is equipped with the ability to detect and repair invalid memory content.If the invalid memory content cannot be corrected, by design the icd will activate the backup mode to ensure patient safety.Please note, while in the safety backup mode the icd therapy is available.Based on the information available for analysis, the root cause of the occurrence of the invalid memory content was not conclusively determinable.However, based on the characteristics of the invalid memory content, a defective component cannot be excluded.Should the icd become available for analysis, this investigation will be updated.

Manufacturer Narrative

(b)(6) 2024 - device explanted and replaced.The device 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 data was inspected.The inspection revealed that the icd activated the safety backup mode, because it detected invalid memory content during the automatic signature check.In general, the icd is equipped with the ability to detect and repair invalid memory content.If the invalid memory content cannot be corrected, by design the icd will activate the backup mode to ensure patient safety.Please note, while in the safety backup mode the icd therapy is available.Based on the information available for analysis, the root cause of the occurrence of the invalid memory content was not conclusively determinable.However, based on the characteristics of the invalid memory content, a defective component cannot be excluded.Should the icd become available for analysis, this investigation will be updated.

• Brand Name: RIVACOR 7 HF-T QP DF4 IS4 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 18993413
• MDR Text Key: 339115181
• Report Number: 1028232-2024-01753
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479156770
• UDI-Public: (01)04035479156770(17)250630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 429532
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Male