BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2388052 · Received December 23, 2011

    Report

    Report Number
    3004209178-2011-10052
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Report Date
    December 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PROGRAMMER: MODEL 37743, SERIAL# (B)(4). ACCESSORY (RECHARGER): MODEL 37752, SERIAL# (B)(4). LEAD: MODEL 3998, LOT# J0527455V, IMPLANTED: (B)(6) 2005, EXPLANTED: NA.

    Additional Manufacturer Narrative · 1

    PROGRAMMER MODEL 37743 SERIAL#, EXTENSION MODEL 3708340 SERIAL# (B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: NA, EXTENSION MODEL 3708340 SERIAL# (B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: NA, ACCESSORY MODEL 37752 SERIAL#, LEAD MODEL 399930 LOT# V182611 IMPLANTED: (B)(6) 2009 EXPLANTED: NA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT THE PATIENT WAS REPROGRAMMED AND THIS ACTION RESOLVED THE ISSUE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION (RIGHT CALF AND KNEE) STARTING AFTER VARIOUS SURGERIES THAT WERE UNRELATED TO THE IMPLANTABLE NEUROSTIMULATOR. THIS HAD BEEN HAPPENING FOR SIX MONTHS OR LONGER. THE PATIENT HAD NOT BEEN MOBILE UNTIL RECENTLY. THE PATIENT HAD TRIED ALL FOUR PROGRAMS WITHOUT SUCCESS, AND WANTED HELP WITH REPROGRAMMING.

    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