BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2450708 · Received February 14, 2012

    Report

    Report Number
    3004209178-2012-00968
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Report Date
    January 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS - EXTENSION MODEL 3708260 SERIAL #(B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: NA; EXTENSION MODEL 37082-20 SERIAL #(B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: NA; LEAD MODEL 399960 LOT #V173511 IMPLANTED: (B)(6) 2009 EXPLANTED: NA; RECHARGER MODEL 37752 SERIAL #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECHARGER SCREEN WAS UNRESPONSIVE AND WAS RESENT. THE PATIENT WAS ALSO NOT ABLE TO ADJUST STIMULATION USING THE PATIENT PROGRAMMER. THE PROGRAMMER DISPLAY SHOWED A CALL YOUR DOCTOR ICON WITH A POWER-ON-RESET (POR) MESSAGE. THE POR WAS CLEARED USING THE PATIENT PROGRAMMER AND THIS ACTION RESOLVED THE ISSUE. THE REASON FOR THE POR WAS NOT REPORTED.

    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