BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2853334 · Received November 30, 2012

    Report

    Report Number
    3004209178-2012-11007
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 5, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V351369, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS NO STIMULATION SENSATION. PATIENT HAD BEEN HAVING SEVERE PROBLEMS FOR ABOUT ONE WEEK AND ATTEMPTED TO REPROGRAM THE DEVICE. PATIENT STATED THEY HAD THE STIMULATION ON PROGRAM 4 AT 6.2 VOLTS AND THEY USUALLY HAD IT AT 4.8 VOLTS. IT WAS ALSO REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT. STIMULATION WAS CONFIRMED AS ON. STIMULATION WAS INCREASED ON PROGRAM 4 AND PATIENT COULD NOT FEEL ANY STIMULATION. PATIENT ATTEMPTED TO INCREASE STIMULATION ON ALL PROGRAMS. STIMULATION WAS TITRATED AS HIGH AS POSSIBLE ON ALL PROGRAMS AND PATIENT FELT NO STIMULATION. PATIENT HAD FALLEN A FEW DAYS PRIOR TO REPORT. PATIENT FELL ON THE SIDE WALK ON THE OPPOSITE SIDE OF THE DEVICE. PATIENT FINGER WAS SWOLLEN ON THE SIDE WHERE THE IMPLANT WAS. PATIENT DID NOT THINK THEY HIT THE SIDE WHERE THE IMPLANT WAS AND ALSO NOTED IT WAS OFF AT THE TIME. PATIENT FINGERS WERE TINGLING BUT NOT THE STIMULATOR. IT WAS ALSO NOTED THE PATIENT FELT THE 'ANTENNA THING THEY HAD ON THEIR BACK VIBRATING BUT NOT INSIDE' AND IT WAS ALSO REPORTED THE PATIENT'S LEFT HAND WAS GOING NUMB. DEVICE STOPPED WORKING AFTER IT GOT TURNED OFF. PATIENT HAD '911' SURGERY IN (B)(6) AND THEIR SYMPTOMS STARTED AFTER THAT. PATIENT'S INTESTINES WERE REMOVED FOR THE SURGERY. PATIENT DID NOT HAVE THEIR PROGRAMMER FOR THE SURGERY SO THEY WERE UNABLE TO TURN OFF DEVICE. PATIENT HAD FELT STIMULATION ON HER FOOT AND LEG. 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
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1