BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2843028 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10701
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 26, 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: 3093-33, LOT# V241655, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-33, LOT# V241655, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING SENSATION WHENEVER SHE WENT THROUGH (B)(4) SECURITY GATES. THE PATIENT STARTED EXPERIENCING THE SHOCKING 3 YEARS AGO. THE PATIENT ALSO NOTICED ABOUT A YEAR AGO SHE STARTED GETTING SHOCKED WHEN A WAND WAS USED; IT WAS NOTED THIS HAD NOT HAPPENED IN THE PAST. IT WAS ALSO REPORTED THE PATIENT'S PROGRAMMING WAS CHANGED BUT SHE WAS UNABLE TO CONFIRM IF IT ACTUALLY CHANGED. THE PATIENT WAS TOLD BY HER PROGRAMMER HER SETTINGS WERE UNUSUAL. IT WAS ALSO REPORTED THE PATIENT STARTED GETTING SHOCKS WHEN LAYING DOWN WRONG 3 DAYS PRIOR TO THIS REPORT. THE PATIENT DID NOT FEEL ANYTHING ON HER IMPLANT UNLESS SHE BUMPED AGAINST SOMETHING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT # 3004209178-2012-10699.

    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