MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA TRANSVENE CS/SVC LEAD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	6937A-35
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that by a patient representative, that the patient is hearing patient alert tones, again.The patient representative indicated they were in clinic last week and apparently had the patient alert tone cleared and, they were told everything looks good with regards to the patient's heart condition.In addition, the patient representative noted they tried to explain the reason for the tone and it was not entirely clear and a bit technical for understanding and noted that was relayed about the patient alert tone had something to do with too much energy passing through the leads.The patient representative was referred to the physician.The right ventricular (rv) lead, epicardial right atrial (ra) lead, epicardial rv lead and epicardial left ventricular (lv) lead remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
B3: date is approximate.Month and year are confirmed valid.Continuation of d10: ddpa2d1 icd implanted: (b)(6) 2023.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: TRANSVENE CS/SVC 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: 23343309
• Report Number: 2649622-2025-29401
• Device Sequence Number: 13129169
• Product Code: LWS
• UDI-Device Identifier: 00643169536012
• UDI-Public: (01)00643169536012(17)231101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

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: 11/01/2023
• Device Model Number: 6937A-35
• Device Catalogue Number: 6937A-35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/20/2025
• 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: 4968-35 LEAD, 4968-35 LEAD, 6937A-35 LEAD.
• Patient Age: 11 YR
• Patient Sex: Male