BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4130211 · Received September 30, 2014

    Report

    Report Number
    3007566237-2014-02785
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING A PROBLEM AND NOTED THAT THIS HAPPENED WITH THEIR PERCUTANEOUS LEADS AS WELL AS THEIR NEW PADDLE LEADS, THEY DID NOT THINK IT WAS A LEAD ISSUE. WHEN THE PATIENT GOES TO BED AT NIGHT, THE PATIENT SLEEPS PROPPED UP ON SEVEN PILLOWS, THREE BEHIND THE HEAD, TWO UNDER THE KNEES AND ONE ON EACH SIDE OF THE PATIENT. THIS KEPT THE PATIENT IN POSITION SIMILAR TO THEIR RECLINER AND IT IS THE ONLY WAY THEY CAN STAY IN BED ALL NIGHT. THE PATIENT DOES NOT MOVE AN INCH DURING THE NIGHT. AFTER THE PATIENT WENT TO BED AND LIED DOWN, THEY COULD FEEL STIMULATION JUST FINE. THEY PATIENT TURNED STIMULATION UP A BIT HIGHER BECAUSE AS THEY LIE THERE, IT IS LIKE SOMEONE WAS SLOWLY TURNING THEIR SETTINGS DOWN. AFTER ABOUT AN HOUR THE PATIENT WAS ONLY FEELING PROBABLY LESS THAN FIFTY PERCENT STIMULATION. AFTER THREE HOURS THE PATIENT WAS FEELING LIKE STIMULATION WAS TURNED OFF, COULD NOT FEEL STIMULATION AT ALL. WHEN THE PATIENT GOT UP IN THE MORNING IT WAS LIKE SOMEONE SLOWLY TURNED SETTINGS BACK UP, AFTER A COUPLE OF HOURS THEY FELT THE NORMAL SENSATION. THE MANUFACTURER REQUESTED A SEPARATE CARD FOR THE READER SO THE MANUFACTURER REPRESENTATIVE COULD DOWNLOAD TWO-WEEK¿S WORTH OF EVERYTHING THE BATTERY DID ON IT AND SENT IT TO THE MANUFACTURER ENGINEERS. THE MANUFACTURER REPRESENTATIVE ATTEMPTED TO SAVE ALL THE REPORTS TO THE CARD SO IT COULD BE SENT TO THE MANUFACTURER BUT TOWARDS THE END OF THE PROCESS THE MACHINE EASED ALL OF THE DATA. THE PATIENT KEPT A TWO WEEK LOG OF ALL THE DIFFERENT TIMES, SETTINGS, AND IN A COUPLE OF WEEKS THEY WOULD TRY TO DOWNLOAD THE DATA AGAIN AND SEND IT TO THE MANUFACTURER. THE PATIENT LOVED THEIR NEW SETTING AND FELT BLESSED TO BE GETTING THE COVERAGE THAT THEY WERE GETTING. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607434 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1