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

Model Number	DTMB1D4
Medical Device Problem Code	Capturing Problem (2891)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	11/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced asystole for fifteen to twenty seconds.The right ventricular (rv) lead was noted to be programmed sub-threshold.Additionally, it was noted that the cardiac resynchronization therapy defibrillator (crt-d) exhibited loss of bi-ventricular support during atrial capture management(acm) operation when the device automatically monitors atrial pacing thresholds at periodic intervals.It was also noted that the crt-d device had not completed acm at the time of the the remote transmission so would have tried at 30 min intervals.In addition, the physician also was questioning the left bundle branch lead.The rv lead, crt-d and left bundle branch lead remain in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: unknown device implanted: (b)(6) 2018, 2088tc lead implanted: (b)(6) 2018.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 further reported that the patient remained in the hospital for an additional day for observation.The rv lead was reprogrammed to increase the safety margin and the capture management feature was programmed off.It was noted that the suspected issue with the left bundle branch lead was determined to be due to the rv lead being programmed subthreshold and capture management running.
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: AMPLIA 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: 23622366
• Report Number: 9614453-2025-04766
• Device Sequence Number: 18400104
• Product Code: NIK
• UDI-Device Identifier: 00763000059675
• UDI-Public: (01)00763000059675(17)240328
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 03/28/2024
• Device Model Number: DTMB1D4
• Device Catalogue Number: DTMB1D4
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 11/23/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/10/2025
• Date Device Manufactured: 10/13/2022
• 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: 383069 LEAD, 6935M62 LEAD
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 68 KG