MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC EXTERNAL PACEMAKER

Model Number 5392

Device Problems Invalid Sensing (2293); Device Operates Differently Than Expected (2913)

Patient Problem Ventricular Tachycardia (2132)

Event Date 08/02/2017

Event Type  Injury  

Event Description

Pt s/p open heart surgery had temporary pacer and wires with pacing rate of 50.On review of the ek, it appeared that the pt's pacemaker had not been properly sensing and was firing without suppression by the pt's own rhythm.Pt developed ventricular tachycardia.Rapid response team activated and resuscitation begun.

• Brand Name: MEDTRONIC EXTERNAL PACEMAKER
• Type of Device: EXTERNAL PACEMAKER
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 6785064
• MDR Text Key: 82470219
• Report Number: MW5071477
• 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: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention
• Patient Age: 64 YR