BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1913556 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-09423
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    August 1, 2010
    Report Date
    November 6, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS NOT SEEN HER PHYSICIAN FOR THE DEVICE IN TWO YEARS. SHE WAS VERY THIN AND HER DEVICE WAS PROTRUDING IN THE BACK AREA. WHEN SHE PRESSED ON THE DEVICE, SHE WOULD GET "SOME RELIEF". IT WAS NOTED THAT HER DAUGHTERS HAVE BEEN VERY ROUGH ON HER BODY FROM PLAYING AND THAT SHE HAD BANGED HER BACK A "FEW TIMES". IT WAS REPORTED THAT SHE HAD A POSSIBLE INFECTION AND FEVER FOR THE PAST 3 MONTHS. SPECIFICALLY, SHE FELT LIKE SHE HAD AN INFECTION IN THE VAGINAL AREA AND IT SEEMED TO HAVE SPREAD TO KIDNEYS. FURTHER 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 27 YR LEAD: MODEL 3889, LOT# V105811| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT# V085160| PROGRAMMER: MODEL 3037, LOT# NJD070903N| EXPLANTED: