BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3120521 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07913
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3889-28 LOT# V293834, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ABOUT THREE YEARS PRIOR TO THE DATE OF THIS REPORT IT WAS REPORTED, THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED, THE PATIENT WOULD NEED TO RUN TO THE RESTROOM OR THEY WOULD ¿LEAK.¿ THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS THAT WEEK PREVIOUS. NO KNOWN FALLS OR TRAUMAS WERE REPORTED. AT THE TIME, IT WAS INDICATED, THE DEVICE WAS ON. THE PATIENT¿S PROGRAM WAS SWITCHED FROM PROGRAM 4 AT 5.0V TO PROGRAM 1 AT 4.1V. AS OF THE DATE OF THIS REPORT, IT WAS STATED, THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS INDICATED THAT THE "DEVICE DID NOT WORK AT ALL FOR" THE PATIENT. THE DEVICE WAS REMOVED AND A NEW ONE WAS IMPLANTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221933 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention