BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2862691 · Received December 10, 2012

    Report

    Report Number
    3007566237-2012-02944
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S "SENSOR" COULDN'T BE RECHARGED, THOUGH IT WAS UNCLEAR IF THIS REFERRED TO THE MEDTRONIC STIMULATOR, THE RESTORE SENSOR. IT WAS STATED THAT THE "SENSOR AND ANTENNA POSITIONS WERE CORRECT." EIGHT EMPTY BLACK BOXES WERE SEEN DURING THE CHARGING PROCESS. IT WAS STATED THAT THE POSITION ARROW DIAGRAM WAS MAX 54, THOUGH IT WAS UNCLEAR IF THIS REFERRED TO THE ANTENNA LOCATE FUNCTION. THE BATTERY STATUS FROM THE "SENSOR" SHOWED IT WAS ¼ CHARGED. IT WAS NOTED THAT THE PATIENT'S WOUND WAS UNHEALED, BUT WAS "GOING WELL." IT WAS NOTATED THAT THERE WAS NO HARM, INJURY, OR DEATH. ABOUT THREE MONTHS LATER, IT WAS REPORTED THAT THE "SENSOR" WAS REPLACED AND THE RECHARGER AND "SENSOR" WERE WORKING CORRECTLY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention