MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE S MRI SURESCAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	6935M97
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: dtmb1d4 crt-d implanted: (b)(6) 2018, 5076-58 lead implanted: (b)(6) 2004.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced an infection and erosion of the abandoned leads from a previous device system.The abandoned leads and active leads were all cut at the tissue and partially removed.The lead bodies remain in the patient.The cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced by a leadless implantable pulse generator (ipg).The patient was administered antibiotics. no further patient complications have been reported as a result of this event.

• Brand Name: SPRINT QUATTRO SECURE S MRI SURESCAN
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13524987
• Report Number: 2649622-2022-03121
• Device Sequence Number: 5397287
• Product Code: LWS
• UDI-Device Identifier: 00643169550926
• UDI-Public: 00643169550926
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/14/2022

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: 11/16/2018
• Device Model Number: 6935M97
• Device Catalogue Number: 6935M97
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/14/2022
• Date Device Manufactured: 12/09/2016
• 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: 6935M55 LEAD, 439688 LEAD, 439688 LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male