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

Model Number	DTBA1D1
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	07/01/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported by a patient family representative that the patient was "shocked for the first time ever when in a pool.The new pool was resurfaced and they replaced the light and it was not grounded properly when it happened." additionally, it was stated that the patient went to the emergency room and the physician could not get the cardiac resynchronization therapy defibrillator (crt-d) device in a diagnostic mode.A field representative arrived and performed a histogram and could see right away when the stray voltage occurred and when the patient got the shock.The family representative also stated that the incident impacted quality of life, and after the incident the patient became irritable as if experienced post-traumatic stress disorder, experienced eye problems and three eye surgeries within three weeks.The patient family representative stated knows that electrical shocks can impact the eye but not sure if it was a direct impact as the patient never had eye problems before the incident.It was also stated that the patient passed away "but from something else, not from this".
Additional Manufacturer Narrative
Continuation of d10: 694965 lead implanted: (b)(6) 2005; 4068-52 lead implanted: (b)(6) 1996.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: VIVA¿ 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: 23559830
• Report Number: 3004209178-2025-19540
• Device Sequence Number: 18682101
• Product Code: NIK
• UDI-Device Identifier: 00643169530140
• UDI-Public: (01)00643169530140(17)180228
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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: 02/28/2018
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/14/2025
• Date Device Manufactured: 08/31/2016
• 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: 419688 LEAD
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Sex: Male