MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA¿ XT DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	DDBB1D4
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Delayed Charge Time (2586)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	01/25/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that an internal review of data transmitted from the implantable cardioverter defibrillator (icd) indicated that more than programmed high voltage energy was delivered.The patient's ventricular fibrillation (vf) episode continued however the device was unable to deliver further high voltage therapy due to a charge circuit time out and external defibrillation was needed to terminate the episode.The patient then experienced additional vf episodes which also required external defibrillation.The patient subsequently passed away.
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
Product event summary: clinical data was reviewed.Analysis of the device memory indicated that the ventricular tachyarrhythmia therapy energy was low due to an unintended current pathway.The ventricular tachyarrhythmia therapy energy was also high, and the high voltage capacitor charge time was longer than expected for a device not yet at elective replacement indicator (eri.) a medical safety assessment was performed for this event.In summary, ventricular tachycardia (vt) occurred and was treated with anti-tachycardia pacing and one high voltage shock, where the delivered energy was higher than the programmed energy and there was a tilt reset.The shock was unsuccessful at terminating the vt and the device was unable to deliver subsequent high voltage therapy due to the triggering of charge time-out.The arrhythmia continued for 37 minutes, degrading into fine vf, and electrograms show external defibrillation converting the arrhythmia to a paced rhythm, then the arrhythmia returning despite several external defibrillation attempts, then no cardiac activity.The device behavior cannot be disassociated from the patient death.It was determined that the cause of the over-delivery of high voltage energy with the tilt reset is related to device design; a non-typical reset of the integrated circuit occurred.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: EVERA¿ XT DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 24777937
• Report Number: 3004209178-2026-05888
• Device Sequence Number: 15949465
• Product Code: LWS
• UDI-Device Identifier: 00643169018082
• UDI-Public: (01)00643169018082(17)160814
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (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): 05/05/2026

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: Lay User/Patient
• Device Expiration Date: 08/14/2016
• Device Model Number: DDBB1D4
• Device Catalogue Number: DDBB1D4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6935M62 LEAD, 5076-52 LEAD.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 79 YR
• Patient Sex: Male