BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2939254 · Received February 1, 2013

    Report

    Report Number
    3004209178-2013-01224
    Event Type
    Injury
    Date Received
    February 1, 2013
    Report Date
    January 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PU
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V071771, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER IMPLANTABLE NEUROSTIMULATOR (INS) REPLACE "ABOUT 3-4 WEEKS AGO", AND THE INS WAS MOVED TO THE OPPOSITE SIDE OF HER BODY DUE TO "SOME DISCOMFORT THE PATIENT WAS HAVING". THE LEAD WAS NOT CHANGED. NO FURTHER INFORMATION ABOUT THIS EVEN WAS REPORTED. IF MORE INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43926 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PU 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention