BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2955633 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02525
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    February 8, 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# V785948, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A CODE 'CEO 0123' AND THAT 'THE PULSATING HAD EXCEEDED WHAT THE PATIENT COULD TOLERATE.' IT WAS STATED THAT THE PATIENT COULD NOT GET THE DEVICE CLOSE TO THEIR BODY BECAUSE 'THE PULSATING WAS TOO STRONG.' IT WAS NOTED THAT THE MANUFACTURE REPRESENTATIVE WAS NOT AWARE OF A CODE 'CEO 0123.' IT WAS LATER REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HER DOCTOR OR MANUFACTURE REPRESENTATIVE ON (B)(6) 2012. THE PATIENT REPORTEDLY WAS STILL HAVING CONCERNS. LATER, IT WAS REPORTED THAT BOTH THE BATTERY AND LEAD WERE REMOVED WITH NO COMPLICATIONS. IT WAS STATED THAT NO OTHER 'HARDWARE' WAS ADDED. DEVICES WOULD NOT BE RETURNED. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59917 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention