BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3230015 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11856
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 24, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# VA080T8, IMPLANTED: (B)(6) 2013: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT FEELING STIMULATION SENSATION. THE PATIENT THOUGHT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON FOR A SHORT TIME POST IMPLANT BUT SYMPTOM CONTROL WAS ¿NEGLIGIBLE.¿ THE INS HAD REPORTEDLY BEEN TURNED OFF SINCE THEN. AT THE TIME OF THE REPORT, THE PATIENT WAS ASSISTED WITH PROPERLY UTILIZING THE PATIENT PROGRAMMER AND ANTENNA IN ORDER TO TURN THE INS BACK ON. THE REPORTER INDICATED THAT WAS THE FIRST TIME IT HAD BEEN TURNED ON TO TRY AND CONTROL THE PATIENT¿S SYMPTOMS IN THE PAST WEEK TO 10 DAYS. THE PATIENT WAS ¿EXTREMELY FRUSTRATED WITH THE DEVICE.¿ IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT WAS GIVEN A NEW PATIENT PROGRAMMER BUT THAT STILL DID NOT WORK. THE PATIENT WAS; HOWEVER, ABLE TO ESTABLISH COMMUNICATION BETWEEN THE PROGRAMMER AND INS AT THE TIME OF THE REPORT, WITH AND WITHOUT THE ANTENNA. THE PATIENT'S INS WAS INDICATED TO HAVE BEEN OFF. WHILE THE PATIENT WAS ATTEMPTING TO TURN DOWN HIS SETTINGS, HE ¿ALL OF A SUDDEN¿ RECEIVED A JOLT WHICH HURT HIM. THIS WAS BECAUSE THE PATIENT ACCIDENTALLY TURNED THE INS ON PRIOR TO DECREASING THE SETTINGS. THE PATIENT¿S AMPLITUDE SETTING WAS DECREASED FROM 3.4V TO 3.3V AND HE COULD FEEL STIMULATION IN HIS ANUS BUT IT WAS ¿VERY STRONG.¿ THEN, THE PATIENT COULD NOT FEEL STIMULATION ANYMORE BUT THE INS WAS STILL ON. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328682 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1