BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2509629 · Received March 29, 2012

    Report

    Report Number
    3004209178-2012-01951
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Report Date
    March 7, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3889-28, LOT# V842736, IMPLANTED (B)(6) 2012, EXPLANTED UNK; PROGRAMMER MODEL 3037, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DOING FINE WHILE WALKING ON A TREADMILL UNTIL SHE INCREASED TO AN UPHILL POSITION, AT WHICH TIME SHE FELT A SHOCKING SENSATION DOWN HER LEFT LEG. ADDITIONAL INFORMATION RECEIVED REPORTED AN IMPEDANCE TEST REVEALED THE IMPLANTABLE NEUROSTIMULATOR WAS WORKING PROPERLY ELECTRONICALLY. THE MANUFACTURER REPRESENTATIVE CREATED FOUR NEW PROGRAMS FOR THE PATIENT TO TRY, NONE OF WHICH USED ELECTRODE #1 AS THE NEGATIVE, AS THAT WAS THE PROGRAM WITH WHICH THE PATIENT FELT SHOCKING. THE SHOCKING SENSATION COULD NOT BE RECREATED BY MOVING THE IMPLANT AROUND IN THE POCKET WITH THE DEVICE BOTH ON AND OFF. THE PATIENT WAS NOT RECEIVING AN EFFECTIVE LEVEL OF THERAPY, BUT WAS GOING TO TRY ALL FOUR PROGRAMS TO SEE IF ANY OF THEM IMPROVED HER SYMPTOMS WITHOUT SHOCKING HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1