MAUDE Adverse Event Report: MEDTRONIC LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 5076

Device Problem Ambient Noise Problem (2877)

Patient Problem Syncope/Fainting (4411)

Event Type  Injury  

Event Description

It was reported that the patient with the pacemaker system was hospitalized due to a syncopal event upon review the pacemaker exhibited non physiologic noisy signals on both channels.It was suspected that the noisy signals were cause by lead on lead abrasion.Subsequently, the pacemaker was explanted and replaced.New leads considered for replacement, nonetheless the veins were occluded.The patient will conclude to be monitored.This lead remains 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: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17525035
• MDR Text Key: 321061528
• Report Number: MW5131977
• Device Sequence Number: 1
• Product Code: DTB
• 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: 07/19/2022

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?: No
• Device Model Number: 5076
• Device Lot Number: PJN725841V
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1