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

Model Number 5348

Device Problem Pacing Problem (1439)

Patient Problem Tachycardia (2095)

Event Date 11/09/2014

Event Type  malfunction  

Event Description

Patient in cvicu had temporary transvenous pacemaker (tvp) programmed at back up rate of 40bpm.Pt was not requiring pacing, pt intrinsic rate sinus rhythm (sr) when pacemaker(pm) spontaneously began pacing at 180bpm.Pt bp stable, pt was disconnected from pacer and resumed intrinsic sr.Another cvicu pacemaker was obtained and attached to patient at same settings as previous.Pt remained stable and with no complication.Pm was collected by leadership and work order put in for biomed.

• Brand Name: SINGLE CHAMBER MEDTRONIC PACEMAKER
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea st. ne; mounds view MN 55112
• MDR Report Key: 4320813
• MDR Text Key: 5207803
• Report Number: 4320813
• 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
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 5348
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR