MAUDE Adverse Event Report: PACESETTER, INC. PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 14BBTC

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported that the right ventricular (rv) lead was explanted due to lead failure.No additional 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, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): PACESETTER, INC.
• MDR Report Key: 17536739
• MDR Text Key: 321271447
• Report Number: MW5143623
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 01/18/2022

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?: No
• Device Model Number: 14BBTC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1