BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3150609 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08740
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STARTED TO EXPERIENCE A CHANGE IN STIMULATION STARTING ABOUT 2 WEEKS PRIOR TO THE DATE OF THE REPORT. THE PATIENT¿S STIMULATION WOULD REPORTEDLY ¿GO UP REAL HIGH¿ AND HE WOULD ¿CONSTANTLY HAVE TO BRING IT DOWN.¿ IT WAS NOTED THAT HE WAS UNABLE TO KEEP IT ADJUSTED. IT WAS FURTHER REPORTED THAT THE PATIENT PROGRAMMER WOULD SAY THAT HE WAS LYING DOWN AFTER HE WAS SITTING FOR 5-6 MINUTES. IT WAS NOTED THAT THIS WOULD HAPPEN IN ALL FOUR PROGRAMS. THE PATIENT ALSO REPORTEDLY HAD FALLEN ABOUT 3 WEEKS PRIOR TO THE DATE OF THE REPORT. IT WAS NOTED THAT HE DID NOT LAND ON HIS BACK AND THE STIMULATION DID NOT CHANGE, BUT THE PATIENT HAD NOT HAD THEIR DEVICE CHECKED SINCE THE FALL. IT WAS ALSO NOTED THAT THE PATIENT WAS SET TO GROUP A PROGRAM 3 IN LYING B @ 2.7V AT THE TIME OF THE REPORT. THE PATIENT WOULD REPORTEDLY DECREASE IT AND A FEW MINUTES LATER IT WOULD FEEL LIKE IT WAS TOO HIGH AGAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT HAVE CONCERNS ABOUT THEIR DEVICE OR THERAPY. IT WAS NOTED THEY RECEIVED ASSISTANCE FROM THEIR HEALTH CARE PROFESSIONAL OR MANUFACTURING REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS REPORTED THAT THE PATIENT HAD APPOINTMENTS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249940 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR