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

Model Number 4194

Device Problems Output above Specifications (1432); Premature Elective Replacement Indicator (1483)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6) 2007 and remains implanted at this time.A call to technical services placed on 10/04/2013 states that high lv output caused the device to have short longevity.L v output was programmed to 6v @2ms, lv threshold was 4.5@2, so device went to elective replacement indicator after a little over 2 yrs.Device had standard depletion based on chronic high output.The physician was dr.(b)(6) at our (b)(6) medical center in (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17520453
• MDR Text Key: 321236238
• Report Number: MW5127401
• 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: 12/17/2013

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