MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL SOLARA CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number	W1TR03
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the patient that their cardiac resynchronization therapy pacemaker (crt-p)'s lower rate limit was supposed to be programmed to seventy beats per minute but at night, the patient's heart rate would dip down to fifty beats per minute.The patient continued, "during the day it will take care of it, it will go into the one-hundreds".The patient stated that they recognized this pattern after wearing their smart watch on and off.The patient stated, "according to the watch, it stays there most of the night and then it bounces back".Additionally, the patient noted that their physician said that they "throw a lot of premature ventricular contractions (pvc)".The device remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: 383069 lead implanted: (b)(6) 2025 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: SOLARA CRT-P MRI SURESCAN
• Common Device Name: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 21654391
• Report Number: 9614453-2025-01114
• Device Sequence Number: 18024310
• Product Code: NKE
• UDI-Device Identifier: 00643169891449
• UDI-Public: 00643169891449
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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: 04/14/2025
• Device Model Number: W1TR03
• Device Catalogue Number: W1TR03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/20/2025
• Date Device Manufactured: 10/23/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4457 LEAD, 4470 LEAD.
• Patient Age: 73 YR
• Patient Sex: Male