BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2535145 · Received April 13, 2012

    Report

    Report Number
    3004209178-2012-02347
    Event Type
    Malfunction
    Date Received
    April 13, 2012
    Report Date
    March 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3889-45, LOT: V250519, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD MODEL 3889-45, LOT: V250519, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD MODEL 3778-60, SERIAL: (B)(4), IMPLANTED: (B)(6)2009, EXPLANTED: NA. EXTENSION MODEL 3708220, SERIAL: (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA. RECHARGER MODEL 37752, SERIAL: (B)(4). PROGRAMMER 37743, SERIAL (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST THEIR STIMULATION. THE PROGRAMMER DISPLAYED THE "CALL YOUR DOCTOR" ICON. THE DEVICE WAS IN A POWER ON RESET (POR) CONDITION. THE POR WAS CLEARED AND THE ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1