BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3900529 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12218
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    January 16, 2008
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-33, LOT# V052573, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S FIRST IMPLANT ABSCESSED THUS IT WAS REMOVED AND THE PATIENT GOT ANOTHER IMPLANT ON THE RIGHT SIDE IN (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377112 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Required Intervention