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

Model Number	6937A-52
Medical Device Problem Codes	High impedance (1291); Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the right ventricular (rv) lead alerted for impedance out of range in the defibrillator coils.It was found that the superior vena cava (svc) epicardial patch had low impedance and had been seen to have high impedance.A chest x-ray shows that the epicardial patch had migrated.The epicardial patch was capped and a new epicardial patch was implanted.It was further reported that a transvenous lead was attempted to be implanted but not used.The transvenous lead had high impedance and failed defibrillation threshold (dft) tests.The lead was removed and a subcutaneous lead was attempted to be implanted.While attempting to implant the subcutaneous lead, the physician nicked the right atrium causing bleeding.The physician had to perform open heart surgery to repair the wound.Since the chest cavity was opened, the physician decided to implant an epicardial patch after the wound was treated.No further patient complications have been reported as a result of this event.

• Brand Name: TRANSVENE CS/SVC
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8437799
• Report Number: 2649622-2019-04665
• Device Sequence Number: 1785312
• Product Code: LWS
• UDI-Device Identifier: 00643169536029
• UDI-Public: 00643169536029
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P980050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2020
• Device Model Number: 6937A-52
• Device Catalogue Number: 6937A-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 23 YR