BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1971601 · Received January 25, 2011

    Report

    Report Number
    3004209178-2011-00610
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    January 13, 2010
    Report Date
    January 19, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD THEIR NEUROSTIMULATOR EXPLANTED DUE TO PERSISTENT PAIN AT THE POCKET SITE. IT WAS NOTED THAT THERE WAS NO CHANGE IN THE POCKET PAIN AFTER THE DEVICE REMOVAL. NO PT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention PROGRAMMER: MODEL 3037, LOT# NJD023123N| LEAD: MODEL 3093, LOT# V011296| IMPLANTED:| EXPLANTED: