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

Model Number	5392
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Codes	Arrhythmia (1721); Cardiac Arrest (1762); Ventricular Fibrillation (2130); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the external pulse generator (epg) incorrectly sensed the t wave and delivered pacing output.It was noted that the sense amplitude function was not working correctly.No patient complications have been reported as a result of this event.
Event or Problem Description
It was further reported that the patient had epicardial wires connected to an external pulse generator (epg) and was maintained on a backup rate.The patient subsequently experienced an r on t event, followed by ventricular fibrillation and cardiac arrest.It was noted that the backup pacing settings prior to the arrest were noted as a rate of 50 beats per minute, sensitivity of 2 millivolts, output of 10 volts, and single chamber fixed rate (vvi) mode.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: analysis was unable to confirm the customer's comment that the external pulse generator (epg) incorrectly sensed the t wave and delivered pacing output.It was noted that the sense amplitude function was not working correctly.The device passed all incoming tests with no anomalies observed.Additionally, it was noted during the visual inspection that the hanger was cracked and all six screws were contaminated.All found defective parts were replaced, and all other identified issues were resolved.The epg then passed all final functional tests.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 50501939
• Report Number: 2182208-2026-50371
• Device Sequence Number: 9432051
• Product Code: DTE
• UDI-Device Identifier: 00763000162443
• UDI-Public: (01)00763000162443(11)240612
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 271 LB