BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3972743 · Received August 1, 2014

    Report

    Report Number
    3007566237-2014-02149
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALL WAS ABOUT A SURGICAL PROCEDURE. THE CALLER WANTED TO KNOW WHAT TO DO AS FAR AS DISPOSAL GOES FOR AN INTERSTIM DEVICE THAT WAS BEING EXPLANTED TODAY. THE CALLER BELIEVED THE IMPLANT WAS BEING REMOVED BECAUSE OF PAIN ASSOCIATED WITH IMPLANT OR LEAD AND NOTED SHE DIDN'T THINK IT WAS BEING REMOVED TO MALFUNCTION. THE CALLER WAS UNCLEAR OF THE REASONS WHY THE IMPLANT WAS BEING TAKEN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450795 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention