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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 10/02/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced a stroke post implant and during normal follow up.The patient was treated and recovered per the physician.The device and lead remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: 429878 lead implanted (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

• 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: 12770837
• MDR Text Key: 280462478
• Report Number: 3004209178-2021-16582
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2021
• Device Model Number: W4TR03
• Device Catalogue Number: W4TR03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/08/2021
• Date Device Manufactured: 07/29/2019
• 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: 5076-52 LEAD, 5076-58 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male