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

Model Number	DTMA1D1
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2026
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 the patient received external defibrillation because the cardiac resynchronization therapy defibrillator (crt-d) did not properly defibrillate them.The crt-d remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: h6 device codes (fdd/annex a) 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
Correction b1, b5, h1, h6 noted that the event was reported for the patient receiving external defibrillation because the cardiac resynchronization therapy de fibrillator (crt-d) did not properly defibrillate them.However, therapies were not delivered as the rates were below the programmed therapy zone; therefore the external defibrillation was not required as a result of a malfunction/not related to the icd/system per formance.There was no malfunction of the device or adverse event that was related to the icd or device system function.The information will be redacted.Incorrect decision made and product is erroneously reported.Supplemental sent to indicate there was no alleg ation against the product.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: CLARIA MRI CRT-D 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: 24184806
• Report Number: 9614453-2026-00309
• Device Sequence Number: 18567627
• Product Code: NIK
• UDI-Device Identifier: 00763000059552
• UDI-Public: (01)00763000059552(17)240628
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2026

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: 06/28/2024
• Device Model Number: DTMA1D1
• Device Catalogue Number: DTMA1D1
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 04/02/2026; 04/02/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 04/07/2026; 04/13/2026
• Date Device Manufactured: 01/10/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 429688 LEAD, 694758 LEAD, 407645 LEAD.
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 76 KG