MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA¿ QUAD XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	DTBA1Q1
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/21/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical product(s): 5076-52, lead implanted: on (b)(6) 2012.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An attorney alleges that during use of the cardiac resynchronization therapy defibrillator (crt-d) the patient presented to facility office for device interrogation.The crt-d interrogation revealed that "the battery was not functioning appropriately and the battery was falling and/or low".The patient was scheduled for a four month follow-up interrogation.Approximately, four months later a routine trans thoracic echocardiogram and treadmill nuclear test were performed and revealed enlarged left ventricle.The nuclear stress test revealed decreased left ventricle function.Approximately, two weeks later the patient presented to the physician's office for care and "the faulty and/or low battery life was noted".The patient was scheduled for a crt-d interrogation for the following week.However, "the battery on the crt-d ran out and/or failed to operate as intended" the next day and the patient expired.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.The device was returned but full analysis could not be performed due to legal restrictions.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.
Event or Problem Description
It was further reported that previous device interrogations provided showed normal device function.One month prior to the patient¿s death, a crt-d check showed an estimated remaining battery longevity of four months.It was indicated on the date of death; the patient experienced cardiac arrest.The cause of death was provided as acute myocardial infarction due to ischemic cardiomyopathy due to multivessel coronary artery disease.
Event or Problem Description
It was further stated by a patient representative that "in (b)(6) 2022 the patient had a sudden cardiac 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.
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 the device was explanted by a forensic pathologist three days post-mortem, who identified no acute heart attack or stroke.

• Brand Name: VIVA¿ QUAD XT CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• 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: 16416344
• Report Number: 3004209178-2023-02414
• Device Sequence Number: 17483372
• Product Code: NIK
• UDI-Device Identifier: 00643169018013
• UDI-Public: (01)00643169018013(17)161228(21)BLD206568H
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/02/2026

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: 12/28/2016
• Device Model Number: DTBA1Q1
• Device Catalogue Number: DTBA1Q1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 03/27/2025; 05/20/2025; 10/06/2025; 02/11/2026
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/08/2025; 06/16/2025; 10/28/2025; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2015
• 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: 429888 LEAD, 693565 LEAD.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White