BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1081961 · Received July 23, 2008

    Report

    Report Number
    3004209178-2008-04278
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    February 1, 2008
    Report Date
    June 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AFTER FALLING ON THE STIMULATOR SITE THREE MONTHS BEFORE THE REPORT. SHE FELT THE STIMULATOR MOVED AT ONE TIME. THE PATIENT REPORTED THAT X-RAYS SHOWED THE IPG HAD MOVED. FOR THE PAST FIVE MONTHS THE PATIENT HAD BEEN SELF CATHETERIZING WITH THE DEVICE ON . IT WAS ALSO REPORTED THAT THE STIMULATION WAS CAUSING PAIN AND VIBRATING SENSATION IN THE VAGINA. THE PATIENT TURNED THE STIMULATION DOWN AND THE PAIN MOVED TO THE LOWER BACK. SHE TURNED THE STIMULATION DOWN TO 2.7 AND "HER STOMACH FELT LIKE IT WAS ON FIRE. SHE STATED THAT THE HEALTH PROFESSIONAL "ACCUSED HER OF TURNING STIM UP TOO HIGH WHERE IT IS DISCOMFORTING FOR THE PATIENT, IN ORDER TO BE ADMITTED TO THE ER AND BE PROVIDED NARCOTICS". THE PATIENT MET WITH THE HEALTH PROFESSIONAL, WHO INSTRUCTED HER TO TURN THE THERAPY OFF. WITH THE THERAPY OFF THE PATIENT WAS BLOTTED AND VERY LITTLE URINE WAS COMING OUT. THE PATIENT TURNED THE THERAPY BACK ON. ONE WEEK LATER THE PATIENT REPORTED PAIN AROUND THE KIDNEYS AND LOWER ABDOMEN. SHE PROVIDED THAT SHE WAS HURT WHILE THE NURSE WAS CATHETERIZING HER. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037| LEAD: MODEL 3093