BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL II

    MDR report key: 3900443 · Received June 27, 2014

    Report

    Report Number
    6000032-2014-00130
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 7433, SERIAL# (B)(4), IMPLANTED: (B)(6) 1992, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1992, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3587A, LOT# L30333, IMPLANTED: (B)(6) 1992, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PATIENT WAS FIRST IMPLANTED IN 1992 THE DEVICE HAD LEAKED IN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377522 ITREL II STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT SOFAMOR DANEK PUERTO RICO MFG 7424

    Patients

    Seq Age Sex Outcome Treatment
    1