MAUDE Adverse Event Report: MEDTRONIC PERMANENT DEFIBRILLATOR ELECTRODES; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 5554

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/18/2013

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6) 1999 and was capped on (b)(6) 2013 due to an unknown reason.The physician was dr.(b)(6) at (b)(6) 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: PERMANENT DEFIBRILLATOR ELECTRODES
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17537275
• MDR Text Key: 321435535
• Report Number: MW5144155
• Device Sequence Number: 1
• Product Code: NIK
• 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: 08/13/2013

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: 5554
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1