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

Model Number W4TR03

Device Problems Failure to Interrogate (1332); Pacing Problem (1439); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 429888 lead implanted (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was no telemetry from the cardiac resynchronization therapy pacemaker (crt-p) and no pacing spikes could be seen on an electrocardiogram (ecg).It was noted that the device was at end of service and was explanted and replaced.No patient complications have been reported as a result of this event.

• Brand Name: SOLARA QUAD CRT-P MRI SURESCAN
• Type of Device: 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13343153
• MDR Text Key: 284373287
• Report Number: 3004209178-2022-01127
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169735682
• UDI-Public: 00643169735682
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/25/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2018
• Device Model Number: W4TR03
• Device Catalogue Number: W4TR03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 01/25/2022
• Date Device Manufactured: 07/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5086MRI45 LEAD, 5086MRI52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female