BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 2965029 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01948
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, IT WAS NOTED THAT THE DISTAL ELECTRODE WAS COVERED IN BLOOD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A 9F INTRODUCER WAS INSERTED UNDER FLUOROSCOPY WITH NO VISUAL OR TACTILE ISSUES. THE RIGHT VENTRICULAR (RV) LEAD WAS INSERTED INTO THE RV OUTFLOW, MANIPULATED TOWARD THE RV APEX WHEN LEAD RESISTANCE WAS FELT. AN ATTEMPT WAS MADE TO RETRACT THE LEAD BUT LEAD RESISTANCE OCCURRED SO THE TEAR AWAY INTRODUCER WAS PEELED OFF WITH SOME DIFFICULTY WHICH DISLODGED THE LEAD FROM THE RV APEX. THE LEAD WAS REMOVED. AUXILIARY ACCESS WAS ATTEMPTED A SECOND TIME WITH A NEW 9F INTRODUCER AND THERE WERE NO ISSUES. THE LEAD WAS REINSERTED TO THE RV OUTFLOW BUT COULD NOT BE RETRACTED. THE PROXIMAL COIL OUTSIDE OF INTRODUCER COULD NOT RETRACT THE LEAD. THE LEAD AND INTRODUCER WERE REMOVED AND A NEW LEAD WAS IMPLANTED USING A 10.5F INTRODUCER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68378 DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR