BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONICS

    MDR report key: 3212621 · Received July 1, 2013

    Report

    Report Number
    MW5030775
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    January 11, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MEDTRONICS NEUROSURGICAL
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I BEGUN TO GET LOWER RIGHT SHOULDER PAIN, ALSO COULD NOT BREATHE AND DOCTORS COULD NOT PINPOINT WHAT WAS CAUSING THIS PAIN. FINALLY MY DOCTOR ORDERED A X-RAY OF MY RIGHT SHOULDER, WHICH SHOWED THE FRACTURED WIRE, MEDTRONIC WAS CALLED IN TO SEE WHAT WAS ALSO CAUSING THE PAIN, WHEN I TOLD THE REP THE REPORT OF THE X-RAY, SHE PACKED HER EQUIPMENT UP AND THE VISIT WAS ENDED WITHOUT OFFERING ME ANY REASON WHAT WAS GOING ON. I DO NOT HAVE THE MODEL NUMBER, THINK THE HOSPITAL RETURNED THE UNIT TO MEDTRONIC'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297281 MEDTRONICS SPINAL CORD STIMULATOR LGW MEDTRONICS NEUROSURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| S