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

Model Number 5392

Device Problems Display or Visual Feedback Problem (1184); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2022

Event Type  malfunction  

Event Description

The external pulse generator (epg) which returned into service subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

Manufacturer Narrative

Product analysis: analysis was able to confirm the customers comment that external pulse generator (epg) displayed an error code.It was noted an error occurred, the main printed circuit board (pcb) board was replaced.The battery shorting bar was contaminated.One case screw was contaminated.All found defective parts were replaced and all other identified issues were resolved.The device then passed all functionality tests.If information is provided in the future, a supplemental report will be issued.

• 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: 13902566
• MDR Text Key: 287902916
• Report Number: 2182208-2022-00911
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00643169725126
• UDI-Public: 00643169725126
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5392
• Device Catalogue Number: 5392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2018
• 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