MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA SUBCUTANEOUS, UNIPOLAR LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6996SQ41
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id dvea3e4 (evx604254s); product type: 0235-icd; implant date (b)(6) 2025; explant date (b)(6) 2025, product id ev240163 (evl009200v); product type: 0264-lead-hv; implant date (b)(6) 2025; explant date (b)(6) 2025.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 during the extravascular implantable cardioverter defibrillator (ev-icd) system implant defibrillation threshold testing (dft) was performed and upon the first attempt high dft thresholds were observed and were unable to successfully convert the patient at 40 joules (j).The procedure was completed.Upon the second attempt at dfts the following day with the addition of the subcutaneous lead, the device was unable to deliver energy for defibrillation, 0j delivered with an impedance value of less than 30 ohms.The ev icd system was explanted the subcutaneous lead was attempted but not used and the patient was implanted with a transvenous system.No patient complications have been reported as a result of this event.
Event or Problem Description
It was further reported that during the implant procedure the first tunnel attempt was probable for being in the pleural space, the second tunnel occurred with no issues and dfts failed at 30j and 40j.The pocket was revised more posterior and slightly more cranial, and dfts failed at 40j and external rescue was required.During the attempted dfts the following day, the high voltage impedance measurement was noted to have decreased and dfts failed again at 40j and required rescue.At this time, the plan on the table was changed to adapt the ev icd lead to a 5019 adaptor and use the subcutaneous lead.
Additional Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.Returned product analysis was performed and no anomalies were found.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: SUBCUTANEOUS, UNIPOLAR LEAD
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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 55112-4391 ; 7635269277
• MDR Report Key: 22161382
• Report Number: 2649622-2025-15380
• Device Sequence Number: 8842372
• Product Code: LWS
• UDI-Device Identifier: 00643169541184
• UDI-Public: (01)00643169541184(17)251105(21)TCR306705V
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2025
• Device Model Number: 6996SQ41
• Device Catalogue Number: 6996SQ41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 106 KG