BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3822020 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09317
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 28, 2014
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V419893, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3093-28, LOT# V419893, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS INDICATED THAT THE CURRENT IMPLANT WAS IMPLANTED IN 2010 AND WAS NOTED THAT SINCE INITIAL IMPLANT, SHE NOTICED A SHOCKING SENSATION WHEN SHE WOULD PASS THROUGH SECURITY SCREENING DEVICES IN STORES. THE PATIENT REPORTED STIMULATION IN THE WRONG LOCATION. IT WAS REPORTED THAT STARTING A WEEK AGO PRIOR TO THE DAY BEFORE THE CALL, PATIENT HAD FELT STIMULATION/VIBRATING ON HER LEFT SIDE. IT WAS INDICATED THAT HER LEFT SIDE FELT REAL TENDER, AND A NUMB FEELING. THE PATIENT FELT BRUISED AROUND INCISION AND SORE. IT WAS INDICATED THAT PATIENT DID NOT HAVE ISSUE WITH INCISION SITE PRIOR TO THIS. IT WAS ALSO NOTED THAT THE ONLY FALL OR TRAUMA PATIENT RECENTLY HAD WAS VERY MINOR. IT WAS NOTED THAT PATIENT WAS ON A BIKE AT ALMOST A STOP; SHE LEANED OVER AND HAD TO JUMP OFF THE BIKE. THE PATIENT HAD TO LIFT HER LEG UP TO GET OVER THE SEAT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300436 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR