BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2923519 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00783
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 29, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA02SSF, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND HER DEVICE HAD NOT BEEN WORKING SINCE SHE WAS IMPLANTED. THE PATIENT ALSO EXPERIENCED A SHOCKING OR JOLTING SENSATION WHEN SHE TRIED TO TURN HER DEVICE OFF. THE DEVICE WAS NOTED TO HAVE JOLTED HER AFTER SHE PRESSED THE OFF BUTTON. IT WAS UNCLEAR WHICH BUTTON THE PATIENT PRESSED AS IT WAS NOTED THAT SHE PRESSED THE ON BUTTON ON HER PATIENT PROGRAMMER. THE REPORTER INDICATED THAT THE PATIENT WAS IN A SITTING POSITION WHEN THAT HAPPENED AND NOT NEAR ANY ELECTROMAGNETIC INTERFERENCE (EMI). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31091 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1