BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1213070 · Received October 23, 2008

    Report

    Report Number
    3004209178-2008-06836
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    July 1, 2008
    Report Date
    September 24, 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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PATIENT WAS EXPERIENCING A BURNING SENSATION WHEN SITTING IN A CHAIR. THE BURNING FEELING WAS AT THE LOCATION OF THE DEVICE POCKET. THE STIMULATOR HAD BEEN IMPLANTED IN MARCH. SOMETIMES IN JULY, THE PATIENT BEGAN HAVING THE BURNING SENSATION IN THEIR BACK, NEAR THE DEVICE, WHEN THEY COUGH OR SIT WRONG IN A CHAIR. THE PATIENT WAS SEEN BY THE PHYSICIAN. NO X-RAYS WERE PERFORMED, BUT ADJUSTMENTS WERE MADE TO THE DEVICE SETTINGS. THE PATIENT CONTINUED TO HAVE INTERMITTENT SYMPTOMS. THE SENSATION WAS REPORTEDLY NOT CONTINUOUS, BUT WAS FELT AT DIFFERENT TIMES WHETHER THE DEVICE WAS ON OR OFF. THE SENSATION WAS LATER DESCRIBED AS A "ZINGING" SENSATION FELT WHEN THE DEVICE WAS ON BUT NOT FELT WITH THE DEVICE OFF. PALPATING THE DEVICE CAUSED THE SENSATION TO BE FELT. TROUBLESHOOTING WAS BEING CONSIDERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742| LEAD: MODEL 3778| LEAD: MODEL 3778