MAUDE Adverse Event Report: Medtronic Europe Sarl Cobalt¿ XT DR MRI SureScan¿; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	DDPA2D1
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Misconnection (1399); Unstable Capture Threshold (3269); Unstable Impedance (4085)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular (rv) lead triggered an alert for rv tip to coil high impedance for a period of time, then impedance of dropped to nominal measurements per the current electrograms (egm).It was also noticed rv threshold had dropped.The rv lead also exhibited a spike and high rv defibrillation impedance, and varying pacing impedance.   additionally, it was noted that during a device generator change out, the physician had a difficult time seating the rv coil into the device header.  a chest x-ray was performed and physician concluded that the x-ray looked okay.  additionally, a healthcare professional concluded nothing pertinent to patient's current status.A device check revealed rv lead, steady, solid impedance and threshold.  pocket manipulation was performed that was unable to create noise. it was further reported that the patient was hospitalized for recurrent syncopal episodes.Review of the remote transmission showed a continuation of high pacing and rv coil impedances on the rv lead.Lead noise was visible with movement and rv coil impedance was variable since the device generator change.A lead revision was scheduled.During the procedure, it was noted that the rv coil lead pin was not properly seated in the implantable cardioverter defibrillator (icd) header.The rv coil lead pin was re-seated in the header.The icd and rv lead remain in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: 693558 lead implanted: (b)(6)-2010.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¿ XT DR 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 ; +1(763)526-9277
• MDR Report Key: 50121936
• Report Number: 9614453-2026-03114
• Device Sequence Number: 13363173
• Product Code: LWS
• UDI-Device Identifier: 00763000178338
• UDI-Public: (01)00763000178338(17)270414(20)02
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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 Model Number: DDPA2D1
• Device Catalogue Number: DDPA2D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: Not provided; 09/26/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/19/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2025
• 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: 5076-45 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 152 LB