MAUDE Adverse Event Report: MPRI SUBCUTANEOUS, UNIPOLAR LEAD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	6996SQ58
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endocarditis (1834); Blister (4537); Swelling/ Edema (4577); Bacteremia (4846)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: mc2vr01 ipg implanted: (b)(6) 2024.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that approximately three months post implant, the patient experienced serratia bacteremia and was treated with antibiotics.Approximately two months later, the patient experienced swelling and a large blister at the device site.The patient also experienced endocarditis.The patient was treated with antibiotics and the implantable cardioverter defibrillator (icd) system was explanted.A previously abandoned leadless pacemaker was reactivated and remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: SUBCUTANEOUS, UNIPOLAR LEAD
• 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: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 21912941
• Report Number: 2649622-2025-11338
• Device Sequence Number: 12579413
• Product Code: LWS
• UDI-Device Identifier: 00643169541177
• UDI-Public: 00643169541177
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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 Model Number: 6996SQ58
• Device Catalogue Number: 6996SQ58
• 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: 04/11/2025
• Initial Report FDA Received Date: 04/25/2025
• Date Device Manufactured: 06/12/2024
• 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: DVPA2D1 ICD, 693558 LEAD.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male