BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3261540 · Received August 2, 2013

    Report

    Report Number
    3004209178-2013-12668
    Event Type
    Malfunction
    Date Received
    August 2, 2013
    Report Date
    July 9, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28, LOT# VA03713, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS LEAKING ALL OF THE TIME AND ALL OVER THE PLACE. IT WAS NOTED THE PATIENT¿S HEALTHCARE PROFESSIONAL REPROGRAMED THE IMPLANTABLE NEUROSTIMULATOR (INS) ABOUT 5 WEEKS PRIOR TO THIS REPORT. IT WAS NOTED THE SYMPTOMS OCCURRED ABOUT 2-3 WEEKS AGO. IT WAS FURTHER NOTED THE PATIENT HAD TWO X-RAYS RECENTLY. IT WAS NOTED THE PATIENT ¿WEARS A THING¿ ON THEIR WRIST THAT SAYS NO MRI OR X-RAY. THE REPORTER STATED ¿OR MAYBE SOMEONE DESTROYED IT, WHICH HAS BEEN DONE BEFORE.¿ IT WAS NOTED THE PATIENT¿S PROGRAMMER WAS NOT WORKING. THE REPORTER STATED ¿IT DOES NOT INSTALL/UPDATE A PROGRAM. IT GOES UP TO 8.5 THEN NOTHING.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD NO STIMULATION SENSATION. IT WAS NOTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE REPORTER STATED THE PATIENT HAD A LOSS OF BLADDER CONTROL AND WAS LEAKING DOWN THEIR LEG. IT WAS NOTED THE PATIENT WAS REPROGRAMMED ABOUT 5 WEEKS PRIOR TO THIS REPORT. IT WAS FURTHER NOTED THE INS WORKED AT FIRST, BUT SINCE THE PAST 3-4 WEEKS THE PATIENT HAD BEEN LEAKING. IT WAS NOTED THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. IT WAS NOTED THE PATIENT REACHED THEIR UPPER LIMIT ON EACH PROGRAM AND WERE CURRENTLY ON PROGRAM 4. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362562 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR