MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. AMPLIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	DTMB1D1
Medical Device Problem Codes	Failure to Charge (1085); Delayed Charge Time (2586)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right atrial (ra) lead exhibited undersensing triggering device classified false termination of atrial tachycardia/atrial fibrillation (at/af) event(s) and inappropriate atrial pacing at times.It was also noted that all atrial tachycardia/atrial fibrillation (at/af) therapies had been disabled due to an atrial lead position check failure.In addition, a charge circuit timeout had occurred as the cardiac resynchronization therapy defibrillator (crt-d) was at end of service (eos).The device was programmed off.The crt-d and ra lead remain implanted.No patient complications have been reported as a result of this event.
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.
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 further reported that the patient presented to the emergency department and is now home on hospice.The patient has declined any additional interventions.
Event or Problem Description
It was reported that the right atrial (ra) lead exhibited undersensing triggering device classified false termination of atrial tach ycardia/atrial fibrillation (at/af) event(s) and inappropriate atrial pacing at times.It was also noted that all atrial tachycardia/atrial fibrillation (at/af) therapies had been disabled due to an atrial lead position check failure.In addition; a charge circuit timeout had occurred as the cardiac resynchronization therapy defibrillator (crt-d) was at end of service (eos).It was also noted that the device triggered an alert for long charge time post recommended replacement time (rrt).The device was programmed off.The crt-d and ra lead remain implanted.No patient complications have been reported as a result of this event.It was further reported that the patient presented to the emergency department and is now home on hospice.The patient has declined any additional interventions.
Additional Manufacturer Narrative
Correction: b5, 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.

• Brand Name: AMPLIA MRI CRT-D SURESCAN
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 23392205
• Report Number: 3004209178-2025-18240
• Device Sequence Number: 18637837
• Product Code: NIK
• UDI-Device Identifier: 00643169929616
• UDI-Public: (01)00643169929616(17)190428
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/06/2026

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: 04/28/2019
• Device Model Number: DTMB1D1
• Device Catalogue Number: DTMB1D1
• 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: 10/05/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 02/06/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/11/2025; 02/06/2026
• Date Device Manufactured: 11/10/2017
• 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: 429688 LEAD, 693565 LEAD, 5076-52 LEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 79 KG