BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1840732 · Received September 17, 2010

    Report

    Report Number
    3004209178-2010-07064
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED (B)(6) 2009 THAT THE PT HAD A LOSS OF THERAPEUTIC EFFECT AND THEIR SYMPTOMS HAD INCREASED. SHE HAD THE DEVICE AT 2.9 AND WAS UNABLE TO INCREASE BECAUSE IT BECAME PAINFUL. IF SHE DECREASED THE AMPLITUDE, HER SYMPTOMS BECAME WORSE. ON (B)(6) 2009, IT WAS REPORTED HER SETTINGS CORRELATED WITH THE SETTINGS HER STIMULATION BOX WAS ON DURING THE STAGE 1 TRIAL, AND SHE FELT STIMULATION IN THE APPROPRIATE "BICYCLE SEAT AREA". ON (B)(6) 2010, IT WAS REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT AND PT REPORTED HER URGE TO GO HAD INCREASED AND HER STIMULATION LEVEL WAS CAUSING HER SORENESS. ON (B)(6) 2010, PT REPORTED WHEN THE STIMULATION WAS TURNED ON SHE HAD MAJOR PAIN IN HER "HOO HOO" AND BACK PAIN AND AN "INTOLERABLE SENSATION TO PEE". THE PAIN OCCURRED AFTER SWIM THERAPY TWO DAYS AGO. PT INDICATED THAT THE PAIN HAD DECREASED. SHE HAD FOUR PROGRAMS AND NONE SEEMED TO WORK FOR HELPING FOR HER SYMPTOMS. PT CHANGED TO PROGRAM 1 AND TURNED THE DEVICE BACK ON. PT COULD FEEL THE STIMULATION BUT IT WAS NOT PAINFUL. PT WOULD TRY PROGRAM 1 TO SEE IF IT HELPS WITH HER SYMPTOMS. ON (B)(6) 2010, PT REPORTED A LOSS OF THERAPEUTIC EFFECT AND INCREASED SYMPTOMS. PT WANTED TO CHANGE TO PROGRAM 3, STIMULATION WAS AT 1.6. ON (B)(6) 2010, PT REPORTED A SHOCKING OR JOLTING SENSATION. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE SYMPTOMS WERE AT THE LEAD LOCATION. PT WAS ON PROGRAM 2 AND SETTING 3.2. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 54 YR EXPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V294701| LEAD: MODEL 3093, LOT# V294701| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD090670N| IMPLANTED:| IMPLANTED: