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

Model Number	5392
Medical Device Problem Codes	Calibration Problem (2890); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the knobs of the external pulse generator (epg) was physically damaged.The epg has been returned for evaluation and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.
Additional Manufacturer Narrative
Product analysis: analysis was unable to confirm the customer's comment that one of the knobs of the external pulse generator (epg) was physically damaged.However, it was noted that the epg failed incoming tests for the rate control knob.It was also noted that the backlight on-off difference test failed.Additionally, one control knob was found detached from the epg but was not damaged.The upper case was observed to be broken around the rate encoder, and the hanger could not be folded into the case.The epg was returned unrepaired due to the expiration of its service life.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: 50517822
• Report Number: 2182208-2026-50456
• Device Sequence Number: 21502364
• Product Code: DTE
• UDI-Device Identifier: 00643169230859
• UDI-Public: (01)00643169230859(11)140514
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• 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?: 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2014
• 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