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	Signal Artifact/Noise (1036); High impedance (1291); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
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 low powered right ventricular (rv) lead placed in the left bundle branch (lbb) exhibited undefined high pacing impedance and the cardiac resynchronization therapy defibrillator (crt-d) was reprogrammed.The following day, the physician opened the device pocket to find that the rv lead was not seated in the device header and ¿completely came out of the header¿ when the device was removed from the pocket.The rv lead was tested with an analyzer, had normal values, and was re-connected to the device.It was then noticed that since the physician had removed the device from the pocket, the right atrial (ra) lead slack had been pulled.The ra lead was then disconnected from the device, slack was added back to the lead, and parameters tested on the analyzer were normal.However, when attempting to re-connect the ra lead back into the header, the physician was unable to engage the setscrew.The physician attempted a new setscrew which was able to connect the ra lead, but before putting the new setscrew into the ra lead port, the physician had pulled the grommet out of the device header.Due to the grommet being pulled off, the ra lead exhibited noise.A new device was implanted, and all lead parameters were within expected ranges.The leads remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.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¿ 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: 24537158
• Report Number: 9614453-2026-00904
• Device Sequence Number: 10372334
• Product Code: NIK
• UDI-Device Identifier: 00763000178222
• UDI-Public: (01)00763000178222(17)260628(20)02
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/28/2026
• Device Model Number: DTPB2D1
• Device Catalogue Number: DTPB2D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2024
• 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: 383074 LEAD, 5076-52 LEAD, 693565 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 104 KG