MAUDE Adverse Event Report: MEDTRONIC; TEMPORARY PACER

Model Number 5348

Device Problems Loss of Power (1475); Low Battery (2584)

Patient Problem Chest Pain (1776)

Event Date 06/22/2015

Event Type  Injury  

Event Description

The pt had temporary pacemaker set at 70 bpm, 15 ma, 0.5 sensitivity.The pt was in a paced rhythm when moved from procedure table to transport cart.Approx one minute after move to transport cart pt's rhythm was asystole and the pt verbalized having chest pain.When inspection the pacemaker it was noted to be turned off with the protective faceplate still in place.The pacemaker was turned on and the pt resumed a paced rhythm.The pt's chest pain resolved after continuation of paced rhythm.The pacemaker low battery light was not on and the cable connection was tight.The pacemaker simply shut off without cause.

• Type of Device: TEMPORARY PACER
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4917720
• MDR Text Key: 6014589
• Report Number: MW5044188
• Device Sequence Number: 1
• Product Code: DTE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5348
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 78 YR
• Patient Weight: 81