BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM NEUROSTIMULATOR, UNKNOWN

    MDR report key: 3800730 · Received May 8, 2014

    Report

    Report Number
    3007566237-2014-01281
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE JUST FOUND OUT ABOUT A CASE WHERE THE PATIENT¿S HEALTH CARE PROVIDER (HCP) SAID THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) MAY BE BAD AND SO IT WAS PULLED. AFTER THE FACT THE MANUFACTURER REPRESENTATIVE GOT A CALL FROM THE HOSPITAL AND BELIEVED THEY WERE GOING TO NEED A KIT TO SEND IT IN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE CALLED THE NURSE WHO INFORMED THEM OF THE POSSIBLE DEFECTIVE DEVICE AND STOPPED BY THEIR AREA TO RETRIEVE IT BUT THEY WERE UNAVAILABLE OR NOT THERE. THEY HAD CALLED THE NURSE A COUPLE OF TIMES AND AGAIN THIS MORNING TO GET THE DEVICE INFORMATION BUT THEY WERE NOT IN THEIR AREA TO GIVE THEM THE INFORMATION BUT WOULD CALL LATER TODAY WITH THE SERIAL NUMBER. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE LEFT A PHONE CALL TO DISCUSS THE REPORT AS WELL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE POSSIBLE DEFECTIVE STIMULATOR WAS REMOVED AND THE MANUFACTURER REPRESENTATIVE WAS INFORMED ABOUT AFTER THE FACT. THE MANUFACTURER REPRESENTATIVE STILL DID NOT KNOW WHAT WAS BAD OR DEFECTIVE ABOUT THE DEVICE AND WAS STILL TRYING TO GET INFORMATION AND CALLED THE HCP¿S OFFICE AS WELL BUT THEY COULD NOT HELP THEM OUT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE HAD NOT GOTTEN A CALL BACK FROM THE CHARGE NURSE REGARDING GETTING THE DEVICE FROM THE PATIENT OR GETTING INFORMATION ABOUT IT AHEAD OR TIME AS THEY WAS TO SUPPOSED TO CALL THEM. THE MANUFACTURER REPRESENTATIVE COULD REACH OUT TO THEM AGAIN AND WOULD BE GLAD TO DO SO. IT WAS NOTED THAT AS FAR AS THE MANUFACTURER REPRESENTATIVE WAS AWARE THERE WAS ONLY 1 INCIDENT AND THIS WAS THE ONLY 1 THEY WERE AWARE OF. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE HAD CALLED THE CHARGE NURSE SEVERAL TIMES AND TRIED TO GET THE NEEDED INFORMATION; HOWEVER, THEY HAD NOT CALLED THEM BACK OR BEEN AVAILABLE TO DISCUSS. THE MANUFACTURER REPRESENTATIVE WOULD RETURN THE PRODUCT IF THEY EVER DID GET THE DEVICE BUT AT THIS POINT A GOOD FAITH EFFORT HAD BEEN MET AND THE DEVICE WAS NOT IN THEIR POSSESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278810 INTERSTIM NEUROSTIMULATOR, UNKNOWN STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention