BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 2954699 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01608
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 11, 2012
    Report Date
    March 13, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. IT WAS NOTED THAT THE DISTAL ELECTRODE WAS COVERED IN BLOOD. THE HELIX WAS BENT AND IT APPEARED VISUALLY TO BE DAMAGED AT IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INITIAL IMPLANT, THE HELIX OF THE RIGHT VENTRICULAR (RV) LEAD WOULD NOT EXTEND AFTER THE FIRST REPOSITIONING. THE RV LEAD WAS NOT USED AND A DIFFERENT LEAD WAS IMPLANTED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59600 DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR