MAUDE Adverse Event Report: Medtronic, Inc. Dual Chamber Temporary Pacemaker; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number	5392
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction

• Brand Name: Dual Chamber Temporary Pacemaker
• Common Device Name: 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: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50206669
• Report Number: 2182208-2026-48579
• Device Sequence Number: 12142948
• Product Code: DTE
• UDI-Device Identifier: 00763000162443
• UDI-Public: (01)00763000162443(11)230310
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150246
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2026

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
• Operator of Device: Health Professional
• Device Model Number: 5392
• Device Catalogue Number: 5392
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown