BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1170709 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05784
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT EXPERIENCED OVERSTIMULATION. THE PT RECEIVED STIMULATION A LITTLE IN BACK AND DOWN THEIR LEGS, HER TOES WERE CURLING. X-RAYS ORDERED BY THE PHYSICIAN REVEALED LEAD MIGRATION, POSSIBLY DUE TO THE PT'S MOTOR VEHICLE ACCIDENT. THE PHYSICIAN PERFORMED A LEAD REVISION DUE TO ONE OF THE EXISTING LEADS MIGRATING. THE STIMULATION WAS NO LONGER IN THE TOES; THE TOES WERE NO LONGER CURLING. IT WAS ALSO REPORTED THAT RECHARGER WOULDN'T HOLD A CHARGE AFTER RECHARGING FOR FIVE HOURS. THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT AT THE DOCTOR'S OFFICE, AND RE-EDUCATED THE PATIENT ON THE PROPER USE OF THE RECHARGING SYSTEM. THE PT APPEARED TO UNDERSTAND THE PROTOCOL FOR RECHARGING, AND IS NOW CHARGING THE RECHARGER APPROPRIATELY. THE MFR REPRESENTATIVE WILL CONTINUE TO FOLLOW UP WITH THE PATIENT TO MAKE SURE THE PATIENT'S PROBLEMS ARE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention EXPLANTED| LEAD: MODEL 3776| EXTENSION: MODEL 37082| EXPLANTED| EXPLANTED| LEAD: MODEL 3487A| RECHARGER SYSTEM: MODEL 37752| LEAD: MODEL 3487A| EXPLANTED| PROGRAMMER: MODEL 37743