MAUDE Adverse Event Report: Medtronic Puerto Rico Villalba Sprint Quattro Secure S MRI SureScan; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	693558
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bacterial Infection (1735); Cardiac Arrest (1762)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately six weeks post implant, the implantable cardioverter defibrillator (icd) system was explanted due to infection and replaced more than two weeks later.The patient reported that they were ¿dead when they did it¿ and they were ¿revived¿ with a machine ¿due to a cardiac arrest.¿ the patient alleged that the infection was a result of one of their ¿contaminated leads¿ and stated the leads had ¿corroded.¿ the patient reported that they did a transesophageal echocardiogram (tee) and ¿saw one of the valves had bacteria on it.¿ the patient noted that the bacteria was not there prior to the surgery.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the proximal portion of the lead was returned, analyzed, and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.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.

• Brand Name: Sprint Quattro Secure S MRI SureScan
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): Medtronic Puerto Rico Villalba; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): Medtronic Puerto Rico Villalba; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50291873
• Report Number: 2649622-2026-24201
• Device Sequence Number: 18824595
• Product Code: LWS
• UDI-Device Identifier: 00643169690035
• UDI-Public: (01)00643169690035(17)270303
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 08/17/2026

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: 693558
• Device Catalogue Number: 693558
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• 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: DDPA2D1 ICD, 5076-52 LEAD.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male