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

Model Number 5392

Device Problem Loss of Power (1475)

Patient Problem Loss of consciousness (2418)

Event Date 03/27/2022

Event Type  malfunction  

Event Description

Pacer 0272935 connected to patient; went dead while pacing patient; pt went unresponsive and symptomatic; backup pacer retrieved and connected immediately; pt regained consciousness without residuals.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC EXTERNAL PACEMAKER
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 14074317
• MDR Text Key: 289190822
• Report Number: MW5108861
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5392
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male