BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2100314 · Received May 16, 2011

    Report

    Report Number
    3004209178-2011-03546
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING/JOLTING SENSATION WHEN SHE LIFTED HER LEGS TO PLACE THEM ON A TABLE. THE STIMULATION SHUT OFF AT THAT TIME. THE "CALL YOUR DOCTOR" ICON WAS SHOWN WITH THE 006 CODE. A BUTTON MAY HAVE BEEN DEPRESSED WHEN THE PATIENT REPLACED THE BATTERIES IN HER PROGRAMMER. THE PATIENT WAS ABLE TO SUCCESSFULLY COMMUNICATE WITH THE DEVICE WITH NEW BATTERIES AND HAD NO FURTHER SHOCKING. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR PROGRAMMER: MODEL 37743, LOT# NKE116278N| LEAD: MODEL 3778, LOT# V170450020| LEAD: MODEL 3778, LOT# V098063030| EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA141586N| IMPLANTED: