BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1980290 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-00821
    Event Type
    Injury
    Date Received
    February 2, 2011
    Report Date
    January 27, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PT HAD A LOSS OF THERAPEUTIC EFFECT. THE PT HAD INCREASED HER STIMULATION, BUT FOUND IT WASN'T AS EFFECTIVE. IT WAS FURTHER REPORTED THAT THE PT HAD AN INFECTION OF THE DEVICE AND LEAD STIES. THE PHYSICIAN HAD NOT DECIDED WHETHER OR NOT TO EXPLANT THE DEVICE. ADD'L 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 Required Intervention EXPLANTED:| PROGRAMMER: MODEL 3037, LOT # NJD116440N| IMPLANTED:| LEAD: MODEL 3389, LOT # V560419