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

Model Number W1TR03

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 10/23/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient passed away one month prior.The patient's spouse noted that the cardiac resynchronization therapy pacemaker (crt-p) was "giving the patient problems" before they passed away.

• Brand Name: SOLARA CRT-P MRI SURESCAN
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
• 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: 10959962
• MDR Text Key: 219953640
• Report Number: 3004209178-2020-21308
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/07/2020

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: 10/28/2019
• Device Model Number: W1TR03
• Device Catalogue Number: W1TR03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/07/2020
• Date Device Manufactured: 04/30/2018
• 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: 5076-58 LEAD, 5076-52 LEAD
• Patient Outcome(s): Death
• Patient Age: 71 YR