MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL COBALT¿ HF CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	DTPB2D1
Medical Device Problem Codes	Pacing Problem (1439); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
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 during use of the cardiac resynchronization therapy defibrillator (crt-d) there was episodes of possible sustained arrhythmias.   with occasional rate below detection zone, which reset the detection counter.The episodes recorded as ventricular tachycardia (vt) non sustained, but possibly more sustained due to occasional beat below detection criteria.  the crt-d remains in use.  no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction b5; additional review of the event shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.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 during use of the cardiac resynchronization therapy defibrillator (crt-d) there was episodes of possible sustained arrhythmias with occasional rate below detection zone, which reset the detection counter.The episodes recorded as ventricular tachycardia (vt) non sustained, but possibly more sustained due to occasional beat below detection criteria. the crt-d remains in use.  no patient complications have been reported as a result of this event.Additional review of the event showed that there was no indication of a detection issue and the crt-d appeared to be functioning as programmed.There is no information to reasonably suggest that the device in this report may have caused or contributed to a serious injury or malfunctioned.

• Brand Name: COBALT¿ HF CRT-D MRI SURESCAN¿
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• 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 55112-4391 ; 7635269277
• MDR Report Key: 24998976
• Report Number: 9614453-2026-01572
• Device Sequence Number: 15892088
• Product Code: NIK
• UDI-Device Identifier: 00763000178222
• UDI-Public: (01)00763000178222(17)210814
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/14/2021
• Device Model Number: DTPB2D1
• Device Catalogue Number: DTPB2D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/19/2026
• Date Device Manufactured: 02/25/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 419678 LEAD, 5076-52 LEAD, 694765 LEAD.
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 106 KG