MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR CRT-D; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number RIVACOR CRT-D

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

Rivacor crt-d & reveal implantable cardiac monitor (icm) implanted in patient.After the biotronik rivacor was no longer interrogatable, the biotronik crt-d was to be replaced with another biotronik rivacor crt-d due to suspected device/telemetry malfunction.During the intervention, the old crt-d was suddenly interrogatable and showed a regular device function.The replacement took place as planned and now the second crt-d is also hardly interrogatable, only with some difficulties and when nearing the programmer head from the side.Suspected interference from the reveal.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RIVACOR CRT-D
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): BIOTRONIK SE & CO. KG
• MDR Report Key: 18875401
• MDR Text Key: 337471669
• Report Number: MW5152553
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/30/2024

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 Model Number: RIVACOR CRT-D
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2024
• Patient Sequence Number: 1
• Treatment: MEDTRONIC INC., REVEAL IMPLANTABLE CARDIAC MONITOR (ICM).