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

Model Number	DDBB1D1
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Codes	Pain (1994); Anxiety (2328)
Date of Event	10/24/2024
Type of Reportable Event	Death
Event or Problem Description
A lawsuit alleged an implantable cardioverter defibrillator (icd) patient was forced to live in a state of fear and anxiety with a l ife-sustaining device the patient knew was failing.The patient was alleged to have sustained severe and conscious pain, suffering, disability, and loss of enjoyment of life in the months leading up to their death.It was alleged that device interrogations and office visits revealed an alarming decline in icd battery life in the setting of a significant increase in dangerous cardiac events, and the patient later complained the "pacemaker alarm has been going off and on for about 1 month" and they were hearing a "beeping sound".A device interrogation four months later revealed that the icd's battery longevity had fallen to only eight months and that the device had reached elective replacement indicator (eri) status.A subsequent device interrogation six months later showed the icd's battery life had further dwindled to only three months.The lawsuit further alleged the defective and failing icd, with a battery that failed prematurely and did not provide adequate warning of its end-of-life status, was not replaced timely, and as a result the patient suffered a fatal cardiac event and died.
Additional Manufacturer Narrative
Continuation of d10: 5568-53 lead implanted: (b)(6) 2006.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 JUNCOS; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO JUNCOS; 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: 23649299
• Report Number: 3004209178-2025-20123
• Device Sequence Number: 9896668
• Product Code: LWS
• UDI-Device Identifier: 00643169018099
• UDI-Public: (01)00643169018099(17)150628
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: 06/28/2015
• Device Model Number: DDBB1D1
• Device Catalogue Number: DDBB1D1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/25/2025
• Date Device Manufactured: 01/11/2014
• 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: 694765 LEAD
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Sex: Female