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

Model Number	DVPB3D4
Medical Device Problem Codes	Pacing Problem (1439); Defibrillation/Stimulation Problem (1573); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Codes	Chest Pain (1776); Discomfort (2330); Shock from Patient Lead(s) (3162)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the emergency department and it was determined that they received inappropriate high voltage therapy and inappropriate anti-tachycardia pacing (atp) for atrial fibrillation (af) with rapid ventricular response that the implantable cardioverter defibrillator (icd) detected as ventricular fibrillation (vf) and the patient experienced chest pain and discomfort from the high voltage therapy.Review of available device and episode data showed an alert indicating that short circuit protection (scp) was triggered during the high-voltage therapy delivery resulting in less than the programmed high-voltage energy being delivered.It was also noted that multiple diagnostic electrical resets triggered during the vf high voltage therapy delivery.Additionally, it was noted that the displayed data appears to be incorrect because of stale data, which is the result of an error in software's processing of the high voltage measurements.The patient was hospitalized and the icd was reprogrammed and 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.
Additional Manufacturer Narrative
Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated that the ventricular tachyarrhythmia therapy energy was low due to an unintended current pathway.Analysis of the device memory had an observation relating to the at/af detection with rapid ventricular response.Analysis of the device memory indicated a partial electrical reset occurred.Analysis of the device memory indicated a partial electrical reset occurred.The device memory indicated an observation related to anti-tachycardia pacing.The device memory indicated inappropriate delivery of ventricular tachyarrhythmia therapy.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.
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 icd was explanted and replaced.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Analysis of the device memory indicated that the ventricular tachyarrhythmia therapy energy was low due to an unintended current pathway.The feedthrough had current leakage (unspecified).The returned device indicated overstress, electrical/arcing in the hybrid.Analysis of the device memory had an observation relating to the at/af detection with rapid ventricular response.Analysis of the device memory indicated a partial electrical reset occurred.Analysis of the device memory indicated a partial electrical reset occurred.The device memory indicated a ventricular tachyarrhythmia therapy (antitachycardia pacing).The device memory indicated inappropriate delivery of ventricular tachyarrhythmia therapy.Optical coherence tomography inspection revealed that there was full dadet delamination on all feedthroughs.Internal visual and x-ray inspection revealed evidence of electrical overstress damage to the hybrid.All this resulted in the observations seen in the field.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: 24269307
• Report Number: 9614453-2026-00461
• Device Sequence Number: 10059069
• Product Code: LWS
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/17/2026

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: 04/14/2022
• Device Model Number: DVPB3D4
• Device Catalogue Number: DVPB3D4
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 03/01/2026; 06/15/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/11/2026; 03/12/2026; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2020
• 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: 2182208-070122-001-R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6935M55 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 240 LB