MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SOLARA CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number	W1TR03
Medical Device Problem Codes	Communication or Transmission Problem (2896); Reset Problem (3019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: 1258t lead, implanted (b)(6) 2012.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 cardiac resynchronization therapy pacemaker (crt-p) was unable to be interrogated by the mobile programmer despite repeated attempts.Interrogation was then attempted using a legacy programmer which displayed a message stating "flash memory failure, error - device (pacemaker) reset.Serious device memory failure.Device should be explanted." it was also noted that the crt-p had many resets which were referred to as a "reset storm".The crt-p was explanted and replaced.The mobile programmer and legacy programmer remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Analysis of the returned device was inconclusive.Analysis of the hybrid revealed the reported failure was confirmed as the device was operating in bubu firmware.The reported por events were also noted in the device reset logs.The device entered bubu mode, while implanted, on april 25, 2024, at 8:47am due to the cumulative por threshold being met.No cause of the bubu failure was determined as the device exhibited nominal operation during pal analysis.No hybrid anomalies were noted.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
Product event summary: the device was returned and analyzed.Analysis of the returned device was inconclusive.Analysis of the hybrid revealed the reported failure was confirmed as the device was operating in bubu firmware.The reported por events were also noted in the device reset logs.The device entered bubu mode, while implanted, on (b)(6) 2024, at 8:47am due to the cumulative por threshold being met.No cause of the bubu failure was determined as the device exhibited nominal operation during pal analysis.No hybrid anomalies were noted.Battery analysis revealed that visual and dimensional inspection results, and electrical testing revealed no abnormalities.The battery performed normally at the time of analysis.Destructive analysis did not identify any internal failure mechanisms that could have contributed to any battery performance issue.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 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: 19460911
• Report Number: 3004209178-2024-12169
• Device Sequence Number: 12465519
• Product Code: NKE
• UDI-Device Identifier: 00643169735675
• UDI-Public: 00643169735675
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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): 09/17/2025

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: 03/28/2020
• Device Model Number: W1TR03
• Device Catalogue Number: W1TR03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 08/26/2025
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 08/23/2024; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2018
• 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: 5086MRI58 LEAD, 5086MRI52 LEAD.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male