MAUDE Adverse Event Report: ST. JUDE MEDICAL VICTORY; PROGRAMMER, PACEMAKER

Model Number 5810

Device Problem Premature Discharge of Battery (1057)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The device was explanted on (b)(6) 2011 due to premature battery depletion.The procedure took place at (b)(6) medical center.The physician was dr (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: VICTORY
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17524331
• MDR Text Key: 321411680
• Report Number: MW5131278
• Device Sequence Number: 1
• Product Code: KRG
• 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: 09/01/2011

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: 5810
• Patient Sequence Number: 1