BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1770261 · Received July 21, 2010

    Report

    Report Number
    3004209178-2010-05653
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 24, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAD A URINARY TRACT INFECTION AND WAS ON ANTIBIOTICS. THREE WEEKS PRIOR TO THIS PT HAD A YEAST INFECTION. ADDITIONAL INFO WAS REQUESTED.

    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 76 YR Other IMPLANTED:| LEAD: MODEL 3889, LOT# V388290| PROGRAMMER: MODEL 3037, LOT# NJD096116N| EXPLANTED: