BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2951394 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01523
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    January 23, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS UNABLE TO ADJUST THEIR STIMULATION. THE PROGRAMMER WAS SHOWING THE "IN THE BOX" ICON. IT WAS STATED THAT THIS ICON HAD APPEARED TWICE. IT WAS NOTED THAT THE PATIENT DOES USE THE ANTENNA LOCATE (AL) FEATURE AND THIS HAS HAPPENED AFTER USING THE AL FEATURE. THE REPORTER WAS INSTRUCTED TO WAIT A FEW SECONDS AFTER PRESSING THE X KEY ON THE RECHARGER. FOUR DAYS LATER IT WAS STATED THAT THE ISSUE WAS RESOLVED. A MEDTRONIC REPRESENTATIVE SAW THE PATIENT, INTERROGATED THE STIMULATOR AND REPROGRAMMED IT, AFTER WHICH, THE ICON WAS REMOVED. IT WAS NOTED THAT THE PATIENT WAS RECEIVING "GOOD" STIMULATION COVERAGE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56969 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR