MAUDE Adverse Event Report: MEDTRONIC IMPLANTABLE PULSE GENERAOR, PACEMAKER (NON-CRT); IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number 4194

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This lv lead was implanted (b)(6)2006 and remains implanted.At a device change out procedure on (b)(6)2011 this lead's pace/sense portion was put in the rv port of the can.This was intentionally done by the physician so that if the pace/sense portion of a lead breaks, it will not oversense and shock inappropriately.The physician was dr.(b)(6) at (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTABLE PULSE GENERAOR, PACEMAKER (NON-CRT)
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17521746
• MDR Text Key: 321315802
• Report Number: MW5128694
• Device Sequence Number: 1
• Product Code: LWP
• 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: 06/03/2011

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: 4194
• Patient Sequence Number: 1