MAUDE Adverse Event Report: MEDTRONIC INC. EXTERNAL CARDIAC PACEMAKER

Catalog Number 5388

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2015

Event Type  Injury  

Event Description

Patient with multiple congenital heart defects requiring external pacemaker.During planned battery change of pacemaker, the devices default battery backup likely failed and the device completely shut off.Prior to the surgery, a second backup was prepared and ready.The care team immediately intervened and installed the second backup pacemaker with no injury to the patient.

• Brand Name: EXTERNAL CARDIAC PACEMAKER
• Type of Device: EXTERNAL CARDIAC PACEMAKER
• Manufacturer (Section D): MEDTRONIC INC.; minneapolis MN 55432
• MDR Report Key: 5195536
• MDR Text Key: 30212526
• Report Number: MW5057589
• 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: Other
• Type of Report: Initial
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5388
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO
• Patient Weight: 6