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

Model Number 5392

Device Problem Mechanical Problem (1384)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) went into doo/emergency pacing mode from ventricular demand pacing (vvi) mode after the doo/emergency button was hit while the patient was walking.The patient suddenly started feeling shocking and the monitor appeared asynchronous.The pacer wires were disconnected and the physician was notified.No further patient complications have been reported as a result of this event.

• Brand Name: DUAL CHAMBER TEMPORARY PACEMAKER
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15796139
• MDR Text Key: 303628414
• Report Number: 2182208-2022-03677
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5392
• Device Catalogue Number: 5392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention