MAUDE Adverse Event Report: ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. LEAD; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1257-40

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported that this lead was explanted due to product performance issue.The lead is no longer in service.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: LEAD
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.
• MDR Report Key: 18860266
• MDR Text Key: 337367224
• Report Number: MW5152502
• 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: 02/07/2024

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: 1257-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Patient Sequence Number: 1