BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3242556 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12150
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 889-28, LOT# V616902, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. HER DEVICE DID WORK AT ONE TIME HOWEVER NOW IT WAS NOT WORKING AT ALL. IT WAS NOTED THAT THE PATIENT HAD ¿TWEAKED HERSELF¿ AND HAD TRIED ALL FOUR PROGRAMS, AND REPORTED THAT SHE HAD TAKEN THE STIMULATION TOO HIGH WHERE THE TINGLING WAS UNCOMFORTABLE. THE PATIENT FELT TINGLING TOWARDS THE RECTUM WHEREAS SHE FELT IT IN THE VAGINA BEFORE. THE SYMPTOMS STARTED TO OCCUR SIX MONTHS INTO IMPLANT. IT WAS LATER REPORTED THAT NO INTERVENTIONS WERE TAKEN OR PLANNED. THE PATIENT HAD SPOKEN TO HER GYN/UROLOGIST A WHILE AGO AND SHE DID NOT SEEM TO TAKE ANY PROACTIVE STEPS IN TRYING TO MODIFY / ENHANCE THE SETTINGS IN THE DEVICE. THE PATIENT WAS FOLLOWING UP WITH HEROB / UROLOGY PHYSICIAN AGAIN TO TRY TO GET FURTHER RELIEF FROM THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CAUSE OF THE EVENT WAS THE IMPLANTABLE NEUROSTIMULATOR (INS). THE FOLLOWING ABNORMAL IMPEDANCE MEASUREMENTS WERE STATED ¿>4000 ALL BUT 3.¿ IT WAS ADDITIONALLY STATED THERE WAS PREMATURE BATTERY DEPLETION. IT WAS NOTED PHYSICIAN TRIED TO REPROGRAM ON (B)(6) 2013, BUT IMPEDANCE WAS BAD. IT WAS ADDITIONALLY NOTED THAT THE PATIENT OUTCOME WAS NO INJURY, BUT THEY HAD URGE INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342349 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR