BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 2951802 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00241
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT: 1156T IMPLANTABLE PACING LEAD (B)(6) 2012. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS T-WAVE OVERSENSING. THE SENSING WAS PROGRAMMED TRUE BIPOLAR AND AND INTEGRATED BIPOLAR. THERE WAS STILL T-WAVE OVERSENSING AT .9MV. THE BLANKING WAS EXTENDED BUT T-WAVE OVERSENSING CONTINUED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57585 TRANSVENE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention (B)(4) BIVENTRICULAR DEFIBRILLATOR