BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2914367 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00564
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 24, 2012
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-33, LOT# V956852, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD BEEN SCHEDULED FOR A REPROGRAMMING APPOINTMENT WITH THEIR HEALTH CARE PROVIDER ON 2012 (B)(6). THE PATIENT CANCELLED THE APPOINTMENT AND HAD SINCE NOT RESCHEDULED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS NO STIMULATION SENSATION AND A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THE DEVICE WAS WORKING INTERMITTENTLY. THE PATIENT HAD BEEN ON ONE CHANNEL AND IT WOULD WORK HALF A DAY OR A DAY OR TWO THEN IT WOULD STOP WORKING. IT WAS NOTED THE PATIENT COULD FEEL IT WHEN IT COMES ON AND STARTED TO STIMULATE. THE DEVICE WAS NOT "HELPING AND THE PATIENT DID NOT FEEL STIMULATION." IT WAS NOTED THE PATIENT HAD TRIED PROGRAM TWO AT 2.6 VOLTS AND NOW PROGRAM 1 AT 2.6 VOLTS. THE DEVICE STOPPED WORKING, THEN THEIR BROTHER ADJUSTED IT, THEN IT STOPPED AGAIN AND IT HADN'T WORKED FOR TWO DAYS. THE DEVICE STARTED WORKING WHEN THE PATIENT PUT THE ANTENNA ON IT. PATIENT WAS ABLE TO ACTIVATE PROGRAM THREE AND FELT STIMULATION COMFORTABLY AT 2.2 VOLTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT WITH LOSS OF BLADDER CONTROL. THE PATIENT HAD LEAKING ISSUES. SYMPTOMS RETURNED ABOUT 1 WEEK AGO AND HE STOPPED FEELING STIM A DAY OR TWO AGO. THE PATIENT SAW A MANUFACTURER'S REPRESENTATIVE ON (B)(6) 2013 BUT HE JUST TALKED TO THE PATIENT AND TOLD HIM EVERYTHING WAS WORKING FINE. THE PATIENT DIDN'T FEEL THE REPRESENTATIVE REALLY GOT THE STIM SENSATION GOING AGAIN. THE PATIENT HAD ONLY FELT STIM SENSATION ONE TIME SINCE THEN. THE REPRESENTATIVE TOLD THE PATIENT THAT PROGRAM 2 WAS THE MOST POPULAR BUT IT DIDN'T HELP THE PATIENT. THE PATIENT WAS CURRENTLY ON PROGRAM 4 AT 3.3V AND WASN'T FEELING ANYTHING. STIM WAS ON. THE PATIENT HAD NOT TRIED INCREASING STIM BEYOND 3.3V. THE PATIENT WAS ABLE TO FEEL STIM AT 4.3V IN HIS BIKE SEAT AREA. THE PATIENT WAS KEEPING A VOIDING DIARY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HAVING TROUBLE, THE DEVICE WAS ON PROGRAM 1 AT 4.0 V, BUT IT WAS ¿TOO HOT AND IT FEELS LIKE SOMETHING WAS STINGING ME.¿ IF THE PATIENT TURNED STIMULATION DOWN TO 3.9 V,HE DID NOT FEEL ANYTHING. IT WAS NOTED THAT YESTERDAY THE PATIENT DID NOT FEEL A THING AND ¿LAST NIGHT I HAD TO CHANGE MY UNDERWEAR AFTER I WENT TO BED.¿ THE PATIENT SAW THE LIGHTNING BOLT, WAS ON PROGRAM 1 AT 3.9 V, AND FELT STIMULATION. IT WAS NOTED THAT THE PATIENT HAD TRIED ALL OF THE PROGRAMS AND SOMETIMES IF HE MAKES A CHANGE IT WILL ¿FEEL GOOD FOR A FEW DAYS THEN WILL STOP WORKING.¿ THE PATIENT STATED THAT ¿SOMETIMES ON SOME OF THESE PROGRAMS, I SIT DOWN AND LEAN FORWARD AND I CAN FEEL A TINGLING, BUT WHEN I STRAIGHTEN UP, IT QUITS.¿ IT WAS REVIEWED WITH THE PATIENT THAT NORMAL MOVEMENTS EFFECT STIMULATION. THE PATIENT TRIED TO INCREASE AMPLITUDE, BUT THEN THE ¿SCREEN CHANGED.¿ IT WAS DETERMINED THAT THE PATIENT WAS PRESSING THE STIMULATION OFF BUTTON INSTEAD OF THE SYNC BUTTON. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19723 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1