BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2951371 · Received February 9, 2013

    Report

    Report Number
    3007566237-2013-00436
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS UNABLE TO ADJUST THEIR STIMULATION. IT WAS STATED THAT THE PROGRAMMER WAS DISPLAYING THE "IN THE BOX" ICON. IT WAS NOT KNOWN IF THE PATIENT WAS USING THE ANTENNA LOCATE FEATURE OR NOT. IT WAS NOTED THAT THE PATIENT LAST RECHARGED THEIR DEVICE APPROXIMATELY TWO WEEKS PRIOR. THE DAY AFTER SHE LAST RECHARGED SHE WENT TO USE THE PROGRAMMER AND GOT THE "BOX" MESSAGE. THE PATIENT WAS STILL RECEIVING STIMULATION AND THEY WERE ABLE TO TURN IT ON OR OFF USING THE RECHARGER, BUT THEY COULD NOT ADJUST STIMULATION WITH THE PROGRAMMER. THREE DAYS LATER IT WAS REPORTED THAT THE PATIENT MET WITH A MEDTRONIC REPRESENTATIVE. IT WAS STATED THAT THE PATIENT HAD "LOCKED UP" HER DEVICE AFTER CHARGING. THE REPRESENTATIVE WAS ABLE TO CLEAR THE "LOCK" WITH THE CLINICIAN PROGRAMMER. IT WAS STATED THAT THE PATIENT WAS USING HER STIMULATION "SUCCESSFULLY". NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57508 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37712

    Patients

    Seq Age Sex Outcome Treatment
    1