MAUDE Adverse Event Report: Medtronic Europe Sarl Cobalt¿ XT VR MRI SureScan¿; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	DVPA2D4
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient commented that "i was in the hospital but did not shock.My heart stopped and nothing happened with the implantable cardioverter defibrillator (icd).Is it even working?  i have not seen a doctor since (b)(6) 2025, only the app is monitoring.On (b)(6) 2027 they said everything was ok with the transmission, when i just got out of the hospital for two months.I do not know if it is working.I do not get it.The heart clinic sent me an appointment for september but they did not  know i was in the hospital for two months.Tomorrow i am going to see a new cardiologist."  the icd remains 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.

• Brand Name: Cobalt¿ XT VR MRI SureScan¿
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): Medtronic Europe Sarl; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): Medtronic Europe Sarl; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50077572
• Report Number: 9614453-2026-03010
• Device Sequence Number: 18727672
• Product Code: LWS
• UDI-Device Identifier: 00763000178468
• UDI-Public: (01)00763000178468(17)260228(20)02
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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: 02/28/2026
• Device Model Number: DVPA2D4
• Device Catalogue Number: DVPA2D4
• 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: 07/09/2026
• Initial Report FDA Received Date: 07/29/2026
• Date Device Manufactured: 09/13/2024
• 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; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female