BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3021960 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04262
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 13, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # V872659, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE WAS NOT WORKING AND THERE WAS A "LOSS OF THERAPEUTIC EFFECT." THE PATIENT SAW "POOR COMMUNICATION" ON THE DEVICE SCREEN. ADJUSTMENTS WERE UNABLE TO BE MADE WITH OR WITHOUT THE ANTENNA. IT WAS STATED THAT "EVERY TIME" THE STIMULATION WAS "ON AND TURNED UP," AN "UNCOMFORTABLE SENSATION" WAS FELT IN THE PATIENT'S VAGINA. THE FEELING WAS FURTHER DESCRIBED AS IF SHE WAS "SITTING ON SOMETHING" OR THAT "A POLE WAS IN HER VAGINA." REPORTEDLY, WHEN SHE WOULD WAKE UP IN THE MORNING, URINE WOULD "FLOOD" OUT. THE PATIENT SUSTAINED A FALL IN THE SHOWER "A COUPLE MONTHS AGO." THE PATIENT DENIED ANY CHANGES, REDNESS, SWELLING, OR HEAT OVER THE POCKET SITE. THE PATIENT WAS REDIRECTED TO HER HEALTH CARE PROVIDER. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123014 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1