MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA SUBCUTANEOUS, UNIPOLAR LEAD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	6996SQ41
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the right ventricular (rv) pacing lead triggered an alert for low impedance.In the years following, the lead triggered two lead integrity alert (lia) due to high rate non-sustained episodes and elevated sensing integrity counter (sic) value.The defibrillation rv lead triggered alerts for undefined high impedance.About five years later, the lead alerted for high impedance.Additionally, the defibrillation superior vena cava (svc) lead triggered an alert for high impedance.All leads remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: 6937a-35 lead implanted: (b)(6) 2020.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: 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 55112-4391 ; 7635269277
• MDR Report Key: 22903622
• Report Number: 2649622-2025-23427
• Device Sequence Number: 7911359
• Product Code: LWS
• UDI-Device Identifier: 00613994568014
• UDI-Public: (01)00613994568014(17)170718
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

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: Lay User/Patient
• Device Expiration Date: 07/18/2017
• Device Model Number: 6996SQ41
• Device Catalogue Number: 6996SQ41
• 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: 07/30/2025
• Initial Report FDA Received Date: 08/27/2025
• Date Device Manufactured: 03/26/2014
• 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: 4968-25 LEAD, DVBC3D1 ICD
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 70 KG