BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 2954667 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02411
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 6, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTING OF A NEW LEAD, THE STABILIZING SLEEVE CUT INTO TWO PIECES FROM THE SUTURE. PART OF THE SLEEVE EMBOLIZED INTO THE LEFT LOWER PULMONARY ARTERY AND THE OTHER PART EMBOLIZED INTO THE RIGHT LOWER PULMONARY ARTERY. THE PHYSICIAN WAS ABLE TO RETRIEVE BOTH PIECES. THE SURGERY WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58584 DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention