BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1655273 · Received April 2, 2010

    Report

    Report Number
    3004209178-2010-02710
    Event Type
    Malfunction
    Date Received
    April 2, 2010
    Date of Event
    February 1, 2010
    Report Date
    March 8, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS TOLD THAT 3 OUT OF 4 ELECTRODES WERE BROKE AND SHOWING OPEN CIRCUITS. THE PATIENT ALSO FELT STIMULATION IN HER FEET. THE PATIENT WAS RE-DIRECTED TO HER HEALTHCARE PROFESSIONAL (HCP). FURTHER INFORMATION FROM THE HCP CONFIRMED THE OPEN CIRCUIT ON THE #3 ELECTRODE, WHICH OCCURRED 2 WEEKS POST OPERATIVE. THE HCP INDICATED THAT THE PATIENT HAS SEVERE/SIGNIFICANT MENTAL ILLNESS AND OFTEN ROCKS TO SOOTHE HERSELF. THE HCP ATTRIBUTED THE EVENT TO THE LEAD, PROBABLY SECONDARY TO THE ROCKING MOTION. THE ROCKING MOTION MAY HAVE DAMAGED THE ELECTRODES. NO SURGICAL PROCEDURES WERE PLANNED AT THIS TIME. THE PATIENT WAS RE-PROGRAMMED TO ANOTHER ELECTRODE CONFIGURATION. THERE WERE NO PATIENT INJURIES.

    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 25 YR IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD100706N| LEAD: MODEL 3093, LOT# V340501