MAUDE Adverse Event Report: BIOTRONIK PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number SENTUS PROMRI

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Event Description

It was reported that this lead was attempted due to unknown product performance issue.The lead was never in service.No adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17533474
• MDR Text Key: 321162993
• Report Number: MW5140378
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: SENTUS PROMRI
• Patient Sequence Number: 1