BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 3152374 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06838
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD WITH THE CATHETER COULD NOT BE SUCCESSFULLY IMPLANTED IN THE ATRIUM. THE P HYSICIAN REPLACED THE LEAD WITH A NEW ONE AND USED A NEW SHEATH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252995 TBD DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 383069

    Patients

    Seq Age Sex Outcome Treatment
    1