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

Model Number	DVPB3D1
Medical Device Problem Codes	Failure to Interrogate (1332); Defibrillation/Stimulation Problem (1573); Impedance Problem (2950); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Codes	Tachycardia (2095); Ventricular Fibrillation (2130)
Date of Event	02/18/2025
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 implantable cardioverter defibrillator (icd) experienced a partial diagnostic electrical reset around the same time a short circuit protection (scp) occurred during high voltage therapy resulting in less than the programmed high voltage energy being delivered for a ventricular fibrillation (vf) episode.It could not be determined if the scp was related to the icd or the right ventricular (rv) lead since details of the shocks were unavailable due to the electrical reset.It was noted that the vf episode was not successfully terminated and there was an increase in rv coil impedance due to the scp.The patient was admitted and had experienced unstable ventricular tachycardia (vt) and vf.It was further reported that the icd could not be interrogated via the monitor.Troubleshooting was done and the icd was able to be interrogated via non-wireless telemetry.The icd was explanted and replaced, and the rv lead remains in use.No further patient complications have been reported as a result of this event.
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.Analysis of the device memory indicated a partial electrical reset.Analysis of the device memory indicated the impedance trend of the right ventricular defibrillation coil was rising.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 indicated a partial electrical reset.Analysis of the device memory indicated the impedance trend of the right ventricular defibrillation coil was rising.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.

• 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: 24552501
• Report Number: 9614453-2026-00933
• Device Sequence Number: 5725518
• Product Code: LWS
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/24/2026

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: 11/14/2021
• Device Model Number: DVPB3D1
• Device Catalogue Number: DVPB3D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 03/11/2026; 05/04/2026; 05/14/2026; 09/23/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/17/2026; 05/13/2026; 05/26/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2020
• 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: 694765 LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male