MAUDE Adverse Event Report: MEDTRONIC TEMPORARY DUAL CHAMBER PACEMAKER

Device Problem Pacing Problem (1439)

Patient Problems Cardiac Arrest (1762); Loss of consciousness (2418)

Event Date 10/21/2015

Event Type  Injury  

Event Description

Temporary medtronic dual chamber pacemaker malfunction occurred to patient.Pacemaker turned off while changing battery.A 15 second 70bpm backup delay for pacemaker to remain on while changing battery failed.Temporary pacemaker was locked in ddd mode with backup rate set at 70 and functioning properly with pt 100 percent a.V.Paced with 100 percent fire and capture prior to battery change.Patient had 14.6 seconds asystole patient lost consciousness.Once pacemaker turned back on patients heart rate went back to 80 (default rate) and pt regained consciousness without any further intervention.Patient postoperative heart surgery had increasing block and eventual pacemaker dependence.Expected to reverse.

• Brand Name: TEMPORARY DUAL CHAMBER PACEMAKER
• Type of Device: TEMPORARY DUAL CHAMBER PACEMAKER
• Manufacturer (Section D): MEDTRONIC ; minneapolis MN 55432
• MDR Report Key: 5187425
• MDR Text Key: 29929606
• Report Number: MW5057496
• 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: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• 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: 82 YR