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

Model Number	DVFB1D4
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); Reset Problem (3019)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Pneumonia (2011); Ventricular Fibrillation (2130); Cardiogenic Shock (2262); Syncope/Fainting (4411)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
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 reported that the patient presented to the hospital experiencing cardiac arrest, pneumonia, lactic acidosis and cardiogenic shock.In addition, the patient was in ventricular fibrillation (vf) for approximately 40 minutes and was unresponsive.Cardiopulmonary resuscitation (cpr) was administered.The implantable cardioverter defibrillator (icd) had potentially reached recommended replacement time (rrt) status unexpectedly.There was suspected premature battery depletion, and two electrical resets occurred.Telemetry was no longer able to be established.A lead impedance warning triggered due to undefined high rv defibrillator coil impedance.The device and lead remain in use.No further patient complications have been reported as a result of this event.
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 the device was explanted and replaced and the lead was capped and replaced.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.The returned device indicated shorting/low impedance in the battery.A nalysis of the hybrid revealed the device was fully functional and operated under normal current drain when powered with an external supply.The device passed all manual therapy delivery testing.There was no evidence of a high current drain condition, and no hybrid anomalies were observed.Analysis of the battery revealed plated lithium was found to initiate from the anode, breaching the anode separator bag, and contacting the cathode tab.Based on this, the premature battery depletion was determined to be the result of a plated lithium short between the anode (negative polarity) and the cathode tab (positive polarity).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: VISIA AF MRI XT VR SURESCAN
• 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: 24225430
• Report Number: 3004209178-2026-01577
• Device Sequence Number: 9366055
• Product Code: LWS
• UDI-Device Identifier: 00643169566422
• UDI-Public: (01)00643169566422(17)180528
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2026

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: 05/28/2018
• Device Model Number: DVFB1D4
• Device Catalogue Number: DVFB1D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 02/03/2026; 05/21/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/18/2026; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1305-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6935M62 LEAD
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 80 KG