MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL COBALT¿ VR MRI SURESCAN¿; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	DVPB3D4
Medical Device Problem Codes	Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the replacement procedure, the implantable cardioverter defibrillator (icd) had problems because part of the right ventricular (rv) lead was stuck inside.It was also noted that the pin of the lead had came off.A different device was successfully implanted and the lead was capped and replaced.It was further reported by the patient that they had initially heard alert tones and didn¿t realize they were coming from their implanted device.The patient reported that when they were out of state, they received a shock and then after that, if they moved their neck a certain way, they got more shocks, receiving four more.Once back home, the patient saw their heart doctor and was told there was noise on the icd and it needed to be replaced.When replacing the device, the surgery took longer as the doctor said a lead was corroded and was broke in half.Later that evening, a lead came loose from the new icd post-surgery, and the patient had surgery the following morning to reattach the lead.The patient said the intravenous (iv) placed had an occlusion and they were never ¿out¿ for the surgery.The patient stated they got a blood clot and were on medication for it.The new icd 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 by the patient that the original lead had corroded and broke in have and that is why the patient was shocked.Additionally, the patient indicated during the surgery the patient had an iv infiltration and left arm swelled enormously and ended up with a deep vein thrombosis (dvt) from the carotid artery to the elbow.
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¿ 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 ; 7635269277
• MDR Report Key: 24511473
• Report Number: 9614453-2026-00874
• Device Sequence Number: 18627771
• Product Code: LWS
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: 12/28/2025
• Device Model Number: DVPB3D4
• Device Catalogue Number: DVPB3D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 07/07/2026
• Date Device Manufactured: 07/09/2024
• 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: 6946M62 LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female