MAUDE Adverse Event Report: ST. JUDE MEDICAL IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number 5610

Device Problems Premature Elective Replacement Indicator (1483); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This device was implanted on (b)(6) 2009 and was abandoned on (b)(6) 2014 due to elective replacement indicator.This device sensed noise on the rv lead.The physician was dr.(b)(6) at (b)(6) clinic and hospital in (b)(6).No other information is available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17536208
• MDR Text Key: 321423967
• Report Number: MW5143098
• Device Sequence Number: 1
• Product Code: DXY
• 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: 07/29/2014

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: 5610
• Patient Sequence Number: 1