MAUDE Adverse Event Report: MPRI TRANSVENE CS/SVC LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6937A-52
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Vasoconstriction (2126); Ventricular Fibrillation (2130)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: ddpa2d1 icd, implanted (b)(6) 2023; explanted (b)(6) 2023.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that following a device upgrade implant procedure, the patient had issues and was immediately brought back to the operating room (or).It was noted that the existing right ventricular (rv) and right atrial (ra) epicardial leads were constricting the coronary arteries.The device system was removed.No further patient complications have been reported as a result of this event.
Event or Problem Description
It was further reported via journal literature that during the upgrade procedure, the patient became suddenly bradycardic and was in cardiac arrest and pulseless electrical activity (pea); advanced cardiopulmonary resuscitation was initiated.A brief return of spontaneous circulation (rosc) was obtained before going into pea again and then ventricular fibrillation (vf).Arterial and central venous catheters were placed during the resuscitation process.Once the patient was stabilized on veno-arterial extracorporeal membrane oxygenation (va-ecmo), left and right cardiac catheterization revealed that the preexisting epicardial lead had wrapped twice circumferentially around the body of the ventricles and was compressing the left coronary artery.After lead extraction, deep indentations remained where the lead had been lodged.A coronary angiogram performed showed relief of the extracardiac compression of the left coronary system.
Additional Manufacturer Narrative
This additional information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.Referenced article: unexpected cardiac arrest during generator change revealing coronary artery strangulation: a case report.A<(>&<)>a practice.2025; 19:e01973.Doi: 10.1213/xaa.0000000000001973.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: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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: 17034872
• Report Number: 2649622-2023-13951
• Device Sequence Number: 15180523
• Product Code: LWS
• UDI-Device Identifier: 00613994492401
• UDI-Public: 00613994492401
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P980050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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 Expiration Date: 11/27/2014
• Device Model Number: 6937A-52
• Device Catalogue Number: 6937A-52
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 11/30/2012
• 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 (X2)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 10 YR
• Patient Sex: Male