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	Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Shock from Patient Lead(s) (3162)
Date of Event	07/07/2026
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 had a procedure using cautery.Prior to the procedure, there were no issues with implantable cardioverter defibrillator (icd) pacing or the patient's heart rate.However, during the procedure the patient's heart rate was interrupted.A magnet was not placed on the patient's icd at the beginning of the procedure.The magnet was placed over an hour into the procedure.At the time the magnet was placed, the patient's heart rate went to forty beats per minute and the device's lower rate was set to that.During the procedure, prior to the magnet being placed, a lead integrity alert (lia) triggered for high rate non-sustained episodes and short ventricular intervals.An abrupt increase in right ventricular (rv) lead impedance was noted along with oversensing noise on the triggering misclassification of events and inappropriate high-voltage therapy.The icd remains in use.No further patient complications have been reported as a result of this event.

• 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--439 ; +1(763)526-9277
• MDR Report Key: 50074826
• Report Number: 3004209178-2026-12727
• Device Sequence Number: 10744043
• Product Code: LWS
• UDI-Device Identifier: 00643169720794
• UDI-Public: (01)00643169720794(17)210514
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/14/2021
• Device Model Number: DVFB1D4
• Device Catalogue Number: DVFB1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 11/21/2019
• 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: 6935M55 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 115 LB