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

Model Number	5392
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the external pulse generator (epg) paced on the t wave while connected to the patient and that the epg was set to ventricular demand mode (vvi) at 60 beats per minute (bpm), which was reported to have caused torsades de pointes.It was noted that the epg was pacing at a rate higher than the patient's intrinsic heart rate.No further patient complications have been reported as a result of this event.
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 56353 -372
• Manufacturer (Section G): Medtronic, Inc.; 8200 coral sea street ne; mounds view MN 56353 -372
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50402777
• Report Number: 2182208-2026-50045
• Device Sequence Number: 10489900
• Product Code: DTE
• UDI-Device Identifier: 00763000162443
• UDI-Public: (01)00763000162443(11)190222
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K150246
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: Other
• Device Model Number: 5392
• Device Catalogue Number: 5392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 02/22/2019
• 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 Sex: Unknown