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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/25/2021

Event Type  Death  

Event Description

It was reported that the patient had expired and the medical examiner's records suggested that there may have been a non-specific failure of the patient's cardiac resynchronization therapy pacemaker (crt-p).Additional information related to the cause of death was requested and is not available.

Manufacturer Narrative

Concomitant medical products: 383069 lead, implanted (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOLARA 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: 12834453
• MDR Text Key: 280927260
• Report Number: 3004209178-2021-17224
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169735675
• UDI-Public: 00643169735675
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/18/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2020
• Device Model Number: W1TR03
• Device Catalogue Number: W1TR03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/18/2021
• Date Device Manufactured: 03/05/2019
• 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: 383069 LEAD, 383059 LEAD
• Patient Outcome(s): Death
• Patient Age: 86 YR
• Patient Sex: Male