BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 2955435 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01367
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH THRESHOLDS IN THE RIGHT VENTRICULAR LEAD AND THAT THE LEAD WAS REPOSITIONED. 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
    59965 DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIODEFIBRILLATOR 2012 (B)(6)