BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1923157 · Received November 9, 2010

    Report

    Report Number
    3004209178-2010-09117
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 16, 2010
    Report Date
    October 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED AN INCREASE IN PELVIC PAIN THAT COULD NOT BE REGULATED FOR 3 DAYS. SHE FELT A "BURNING SENSATION" AND HAD AN INCREASE IN URINARY FREQUENCY. ACCORDING TO THE PT, HER HEALTH CARE PROFESSIONAL AND A MANUFACTURER'S REPRESENTATIVE BOTH TOLD HER "ONE LEAD IS NOT WORKING AS DETERMINED DURING IMPLANT SURGERY." ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP 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 65 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD107648N| LEAD: MODEL 3093, LOT# V514001| EXPLANTED:| STIM ACCESSORY: MODEL 3550-18, LOT# W59940| EXPLANTED: