BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2032458 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02295
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IN A NURSING HOME DUE TO A STROKE, DEVELOPED SORES AND EROSION OCCURRED. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED. THE PT HAD A NEW INS AND LEAD IMPLANTED IN THE ABDOMINAL AREA. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 64 YR Required Intervention IMPLANTED:| LEAD: MODEL 3093, LOT# V063306| PROGRAMMER: MODEL 3037, LOT# NJD077825N| EXPLANTED: