MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VISIA AF XT VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	DVAB1D1
Medical Device Problem Codes	Battery Problem (2885); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Analysis of the returned device was inconclusive.Could not determine the root cause of the battery depletion that resulted in the device no telemetry condition.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The implantable cardioverter defibrillator (icd) was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.

• Brand Name: VISIA AF XT VR
• 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: 22784855
• Report Number: 3004209178-2025-13670
• Device Sequence Number: 13238322
• Product Code: LWS
• UDI-Device Identifier: 00643169566347
• UDI-Public: (01)00643169566347(17)180728
• 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: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/28/2018
• Device Model Number: DVAB1D1
• Device Catalogue Number: DVAB1D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2017
• 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: 712165 LEAD.
• Patient Sex: Male