BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3130585 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08199
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# VA04H0Z, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE THE REVISION YET. IT WAS SCHEDULED FOR ¿NEXT WEEK.¿ TWO WEEKS LATER IT WAS REPORTED THAT PATIENT DID HAVE THE REVISION SURGERY ON (B)(6) 2013. THE PATIENT WAS REPORTED TO BE DOING WELL. TWO DAYS LATER IT WAS REPORTED THAT THE LEAD WAS REVISED AND THE GENERATOR WAS MOVED TO THE OTHER SIDE. THE PATIENT HAD NOT YET BEEN SEEN BY THE HEALTH CARE PROVIDER FOR POST-OP.

    Description of Event or Problem · 1

    ABOUT TWO WEEKS PRIOR TO THE DATE OF THIS REPORT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT ALSO EXPERIENCED PAIN WHEN STIMULATION WAS TURNED UP TO ¿AVERAGE STIMULATION SETTINGS.¿ THE PAIN WAS FELT IN THE BICYCLE SEAT AREA AND WAS ONLY FELT WHEN STIMULATION WAS TURNED ON. IT WAS NOTED THE PATIENT HAS HAD FOUR REPROGRAMMING SESSIONS, WHICH WERE UNSUCCESSFUL IN ELIMINATING THE PATIENT¿S PAIN. THE PATIENT WAS NOT HAVING URINARY SYMPTOM CONTROL AS WELL. ALL IMPEDANCES WERE WITHIN ¿NORMAL RANGE.¿ CYCLING, PULSE WIDTH, AND RATE HAVE ALL BEEN ADJUSTED, WITHOUT RESOLVE FOR THE PATIENT. AS OF THE DATE OF THIS REPORT, IT WAS INDICATED THE HEALTHCARE PROVIDER WAS TO SCHEDULE THE PATIENT FOR A REVISION. ABOUT TWO WEEKS LATER, IT WAS CONFIRMED THE PATIENT WAS SCHEDULED FOR A REVISION ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231452 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention