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

Model Number 53401

Device Problems Mechanical Problem (1384); Use of Device Problem (1670)

Patient Problem Diaphoresis (2452)

Event Date 09/01/2020

Event Type  Injury  

Event Description

It was reported that while connected to the external pulse generator (epg) as the patient was brought into the procedure room and moved to the procedure table they stated "i don't feel good" and became slightly diaphoretic.It was also reported that when the technologist checked the epg it was flashing red and when the epg battery slot was opened no batteries were present.The patient was placed on a defibrillator monitor and was actively pacing.An alternative epg was connected to the patient and the patient's symptoms subsided.It was noted that the patient did not lose consciousness during the event.It was further reported that the epg easily ejected the battery compartment.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: TEMPORARY EXTERNAL 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: 14248534
• MDR Text Key: 290367858
• Report Number: 2182208-2022-01373
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 53401
• Device Catalogue Number: 53401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• 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): Required Intervention