BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2977371 · Received February 25, 2013

    Report

    Report Number
    3004209178-2013-03053
    Event Type
    Injury
    Date Received
    February 25, 2013
    Report Date
    February 9, 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
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V012043, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM STOPPED WORKING FOLLOWING A FALL. SPECIFICALLY, IT WAS REPORTED THAT THE "LEAD OR SOMETHING PULLED LOOSE OR WAS DAMAGED". IT WAS ALSO NOTED THAT THE INS SYSTEM DID WORK "FINE" FOR THE FIRST 2 YEARS FOLLOWING IMPLANTATION. IT WAS REPORTED THAT THE DEVICE WAS SUBSEQUENTLY REPLACED (MANUFACTURER'S DEVICE REGISTRY INDICATED THAT ONLY THE INS COMPONENT WAS REPLACED). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80490 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention