BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3169409 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10353
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    June 10, 2013
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 355018, LOT# W59955, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 041829, LOT# N272716, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3889-28, LOT# V623317, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3889-28, LOT# V623317, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED ON (B)(4) 2011 THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. ABOUT THREE MONTHS LATER, IT WAS REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THE DEVICE OR THERAPY BUT HAD SOUGHT FURTHER ASSISTANCE. AN APPOINTMENT WAS SCHEDULED FOR (B)(6) 2012. ABOUT A YEAR AND THREE MONTHS LATER, IT WAS REPORTED THAT THE PATIENT HAD HAD ¿BAD EXPERIENCES¿ SO FAR. THE PATIENT¿S FIRST DEVICE WAS REMOVED AND REPLACED BECAUSE IT WAS ¿NOT WORKING RIGHT.¿ THE PATIENT STATED THAT THE ¿STIMULATION WIRES¿ WERE ALSO ¿READJUSTED AND SO FORTH.¿ THIS OCCURRED IN (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270419 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention