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 Codes	Angina (1710); Arrhythmia (1721); Bradycardia (1751); Cardiac Arrest (1762); Dyspnea (1816); Unspecified Infection (1930); Muscle Weakness/Atrophy (1967); Pulmonary Edema (2020); Discomfort (2330); Asystole (4442); Swelling/ Edema (4577); Kidney injury (4882)
Date of Event	05/06/2025
Type of Reportable Event	Death
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.
Event or Problem Description
It was reported that a patient underwent mitral valve and tricuspid valve repair surgery on (b)(6) 2025.Following the procedure, the patient was connected to an external pulse generator (epg) to provide pacing support.It was noted that the epg¿s settings were reportedly established and monitored.On (b)(6) 2025, the epg misfired while it was connected, resulting in an r-on-t phenomenon at a vulnerable point in its rhythm which led to a cardiac arrest.It was noted that the patient experienced severe pain, fear, and physical distress for many hours prior to death.It was reported that the patient subsequently died.
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.
Event or Problem Description
It was further reported that post- surgery patient required intensive care for breathing support and heart rhythm management and developed acute kidney injury and worsened kidney function.Needed blood thinners and special cardiac diet.Chest x-rays showed some fluid in his lungs and possible infection.Persistent heart rhythm problems (bradycardia and arrhythmias) and required temporary pacemaker support.Experienced weakness, difficulty with mobility, and increased oxygen needs.He had mild, well-controlled pain at his incision and chest tube sites and had swelling in his legs.
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.
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 55112-4391 ; 7635269277
• MDR Report Key: 23207092
• Report Number: 2182208-2025-05090
• Device Sequence Number: 18431719
• Product Code: DTE
• UDI-Device Identifier: 00643169230859
• UDI-Public: (01)00643169230859(11)140514
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/28/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 11/03/2025; 01/23/2026; 04/27/2026
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 11/17/2025; 01/27/2026; 04/28/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 100 KG