BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1910990 · Received November 23, 2010

    Report

    Report Number
    3004209178-2010-09877
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    June 9, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD THEIR NEUROSTIMULATOR EXPLANTED DUE TO VARIOUS INFECTION AND INFLAMMATION ISSUES. THE PT HAD AN APPOINTMENT TO SEE THE PHYSICIAN BUT CANCELLED AND HAD NOT BEEN SEEN SINCE THE EXPLANT PROCEDURE.

    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 77 YR Required Intervention EXPLANTED:| LEAD: MODEL 3093, LOT# V307391| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD089650N