BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 3153073 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05808
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. CONCOMITANT PRODUCTS: C315S502 CATHETER (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ATTEMPTED IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD, THRESHOLDS TESTED BAD. THEREFORE THE LV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255130 TBD DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR