BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 3152304 · Received June 7, 2013

    Report

    Report Number
    6000023-2013-00020
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC, B.V.
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH HVB (HIGH-VOLTAGE 'B') IMPEDANCE. THE LEAD REMAINS IN USE, HOWEVER THERE IS A PLANNED REVISION SURGERY FOR PLACEMENT OF A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE EXTRACTION OF THE LEAD WAS ATTEMPTED. HOWEVER, IT WAS UNSUCCESSFUL AND THEREFORE THE LEAD HAS BEEN CAPPED AND LEFT IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252884 TRANSVENE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MEDTRONIC, B.V. 6966

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R