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

Model Number	W4TR02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endocarditis (1834); Sepsis (2067)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) system was explanted and replaced due to sepsis/endocarditis.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Concomitant products:429888 lead, implant date: (b)(6) 2017.Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.The device was returned and screening analysis was performed, but no issue was identified requiring full analysis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SERENA QUAD 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13677885
• Report Number: 3004209178-2022-02864
• Device Sequence Number: 12010974
• Product Code: NKE
• UDI-Device Identifier: 00643169735668
• UDI-Public: 00643169735668
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/28/2019
• Device Model Number: W4TR02
• Device Catalogue Number: W4TR02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2017
• 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: 5086MRI45 LEAD, 5086MRI52 LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male