BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL II

    MDR report key: 3811360 · Received May 15, 2014

    Report

    Report Number
    1030489-2014-02520
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3586, SERIAL# (B)(4), IMPLANTED: (B)(6) 1994, PRODUCT TYPE: LEAD. PRODUCT ID: 7496-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1994, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) DID NOT LAST MORE THAN 5-6 MONTHS. IT WAS NOTED THEY DID NOT GET IT REPLACED RIGHT AWAY BECAUSE THEY WERE NOT FULLY HEALED FROM THE IMPLANT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. THEY REPLACED THE ¿BEEPING DEVICE¿ ON 2014-(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290780 ITREL II STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT SOFAMOR DANEK PUERTO RICO MFG 7424

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR