BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2574638 · Received May 15, 2012

    Report

    Report Number
    3004209178-2012-03291
    Event Type
    Malfunction
    Date Received
    May 15, 2012
    Report Date
    April 19, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYP LEAD, PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYP RECHARGER, PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYP PROGRAMMER, PATIENT PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYP EXTENSION, PRODUCT ID 3487A-56, LOT# V085460, IMPLANTED: 2008 (B)(6), PRODUCT TYP LEAD, PRODUCT ID 3487A-56, LOT# V083355, IMPLANTED: 2008 (B)(6), PRODUCT TYP LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST THEIR STIMULATION. THE PATIENT PROGRAMMER DISPLAYED A 'CALL YOUR DOCTOR' ICON AND HAD A 'POWER ON RESET' (POR) CONDITION. THE POR COULD NOT BE CLEARED BY THE PATIENT AND THEY WERE INFORMED THEY WOULD HAVE TO SEE THEIR DOCTOR OR A COMPANY REPRESENTATIVE TO CLEAR THE CONDITION. IT WAS NOTED THAT THE PATIENT WAS STILL ABLE TO CHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS) AND IT WAS ¾ CHARGED. IT WAS ALSO NOTED THAT THE PATIENT HAD RECENTLY HAD ABDOMINAL SURGERY AND HAD NOT USED THE INS 'IN A WHILE.' ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION SHOWED THE PATIENT NO LONGER HAD ANY CONCERNS WITH THEIR DEVICE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1