MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number MEDTRONIC 5348

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/25/2013

Event Type  No Answer Provided  

Event Description

Patient asystolic on monitor.Temporary pacemaker box was off; during prior check and battery change device was functioning.Changed box and patient returned to paced rhythm.

• Brand Name: MEDTRONIC
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mailstop mvs11; mounds view MN 55112
• MDR Report Key: 3578256
• MDR Text Key: 4137229
• Report Number: 3578256
• 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: 01/13/2014

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?: *
• Device Operator: Invalid Data
• Device Model Number: MEDTRONIC 5348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR