BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3223696 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11677
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37746, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD STIMULATION OFF AND HAD LAID DOWN. IT WAS THEN TURNED BACK ON. IT WAS NOTED THAT AFTER LOUNGING WITH FEET UP, THE PATIENT ROLLED OVER AND INSTANTANEOUSLY FELT A ¿HOT PAIN LIKE A PIECE OF HOT COAL RIGHT WHERE THE POCKET WAS.¿ THE HEAT LASTED UNTIL THE STIMULATION WAS TURNED BACK OFF. THE HEAT WAS SO INTENSE IT WAS ¿ALL THE PATIENT COULD THINK OF.¿ A COLD ICE PACK WAS PLACED OVER THE POCKET SITE. THE POCKET WAS NOT FEELING WARM ON THE DATE OF THIS REPORT. THE PATIENT FELT THE DEVICE HAD NOT MOVED BUT FELT LIKE IT WAS ¿BRUISED.¿ THE POCKET HAD FELT LIKE THIS SINCE THE IMPLANT DATE. NO SWELLING OR REDNESS WAS NOTICED. NO FALLS OR TRAUMA WAS REPORTED. THE EVENT OCCURRED ONE DAY PRIOR TO THE DATE OF THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323785 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR