MAUDE Adverse Event Report: MEDTRONIC EXTERNAL PACEMAKER

Model Number 5392

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2018

Event Type  malfunction  

Event Description

Pt questioning tech regarding why there was no lights on the pacemaker box.The tech went to get the nurse to answer his questions regarding the device.Upon nurse's arrival to room, temporary pacemaker device had been turned on by the pt.The nurse questioned the pt and he reported he thought it was supposed to be on.The nurse educated the pt to not touch the buttons and that it was supposed to be off.

• Brand Name: EXTERNAL PACEMAKER
• Type of Device: EXTERNAL PACEMAKER
• Manufacturer (Section D): MEDTRONIC; mounds view MN 55112
• MDR Report Key: 7365644
• MDR Text Key: 103433959
• Report Number: MW5076018
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• 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: 03/21/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5392
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR