MAUDE Adverse Event Report: MEDTRONIC MODEL 5348 SINGLE CHAMBER TEMPORARY PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5348

Device Problems Device Alarm System (1012); Loss of Power (1475)

Patient Problem Cardiac Arrest (1762)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

Temporary pacer with epicardial wires stopped working.As patient is a-v paced and dependent she went asystolic and required immediate intervention of external transcutaneous pacing, which occurred.This happened twice.Battery was changed in-between both product failures and same result occurred.Batteries had been newly placed just prior to implantation.The battery light indicator never flashed or indicated that the battery was the issue.All wires were properly placed and confirmed by staff members.External medtronic pacer box sent to clinical engineering and they were not able to replicate the event under their evaluation of the device.This device malfunctioned; stopped working abruptly without any indication or warning of failure.This device was being operated by the clinical staff during the time of failure.Patient became asystolic after the external pacer stopped pacing.Another external pacer was immediately attached to the patient and patient returned to normal paced rhythm.Upon further investigation, we have determined that there have been other cases in the past with these devices in our hospital abruptly stop pacing without warning despite brand new batteries in these units.Medtronic was made aware of these events and historically these devices have sent back to manufacturer for their evaluation.It was reported back to us from the manufacturer that there were no issues upon there examination.

• Brand Name: MODEL 5348 SINGLE CHAMBER TEMPORARY PACEMAKER
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 3628538
• MDR Text Key: 18622586
• Report Number: 3628538
• Device Sequence Number: 1
• Product Code: DTE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 5348
• Device Catalogue Number: 5348
• Device Lot Number: 5348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2014
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2014
• Patient Sequence Number: 1
• Patient Age: 85 YR