BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3930179 · Received July 11, 2014

    Report

    Report Number
    3004209178-2014-12930
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    June 20, 2014
    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)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 093-28, LOT# V913910, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD BEEN HAVING SOME ACCIDENTS AND NO LONGER FELT STIMULATION STARTING AROUND A MONTH AGO. IN THE PAST MONTH, THE PATIENT HAD HAD THREE FALLS AND AFTER HER FIRST FALL SHE DID THE ¿BUTT SCOOT¿ TO THE STEPS OF HER GARAGE SO SHE COULD PULL HERSELF UP. SHE ASKED IF THE ¿BUTT SCOOT¿ WOULD HAVE DISLODGED HER COMPONENTS. THERE WAS A LOSS OF THERAPEUTIC EFFECT AND THE PATIENT WANTED HELP MAKING ADJUSTMENTS TO HER STIMULATION. SHE HAD NOT MADE ADJUSTMENTS BEFORE, AND IT HAD PREVIOUSLY BEEN DONE AT THE DOCTOR¿S OFFICE BUT IT HAD BEEN QUITE A WHILE. THE PATIENT¿S STIMULATION WAS ON, AND SHE WAS ON PROGRAM 2 AT 1.45. THE PATIENT WANTED TO INCREASE TO SEE IF FEELING STIMULATION WOULD HELP HER SYMPTOMS, AND SHE INCREASED FROM 1.45 TO 1.90. THE PATIENT FELT STIMULATION IN HER LOWER SPINE. ADDITIONAL INFORMATION 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
    406772 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR