BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1960933 · Received January 11, 2011

    Report

    Report Number
    3004209178-2011-00274
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. SHE HAD LOST 50 PLUS POUNDS OVER THE PAST FEW YEARS AND HER NEUROSTIMULATOR HAD NOT BEEN EFFECTIVE. IT WAS NOTED THAT HER "WIRES" WERE PROTRUDING FROM HER BODY AND IT WOULD GET CAUGHT ON SUCH THINGS AS DOORS. SHE HAD BEEN AT THE GROCERY STORE WHERE HER LEAD WAS "SNAGGED" ON A CART AND "PULLED HARD". ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention PROGRAMMER: MODEL 3031A, LOT#: NGM020796P| IMPLANTED:| EXTENSION: MODEL 3095, LOT#: NAH004288V| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT#: J0527104V