BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3160158 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10057
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, 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 HAD MULTIPLE FALLS OVER THE LAST COUPLE YEARS PRIOR TO THE DATE OF THE REPORT. IT WAS NOTED THAT THESE FALLS WERE ¿OFF AND ON¿ DUE TO UNEXPLAINED PASSING OUT. IT WAS FURTHER REPORTED THAT THE PATIENT HAD LANDED ON EVERYTHING FROM CONCRETE, TO CARPET, TO ASPHALT, TO PEOPLE, AND FELL OFF A SEVEN FOOT TALL LADDER. IT WAS THEN REPORTED THAT ABOUT 6 MONTHS PRIOR TO THE DATE OF THE REPORT THE PATIENT NOTICED THAT THE SIDE OF THE INS WAS ¿ROUGH¿ OR ¿CHIPPED¿OR LIKE THERE WAS A ¿DENT.¿ IT WAS REPORTED THAT NO OTHER CHANGES AT THE POCKET SITE. IT WAS NOTED THAT THE FALLS WERE RANDOM AND SOMETIMES THEY WOULD HAPPEN WHEN HE TURNS HIS HEAD TOO QUICKLY, AND SOMETIMES THE PATIENT WOULD JUST PASS OUT WITHOUT KNOWING WHY. IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT REPORTEDLY NOTICED THE YEAR PRIOR TO THE REPORT THAT THE STIMULATION COULD NOT ¿OVER POWER THE PAIN.¿ IT WAS ALSO REPORTED THAT THE PATIENT COULD NOT ADJUST STIMULATION AND THAT A "COUPLE TIMES" THAT PATIENT WAS UNABLE TO TURN THE DEVICE OFF FOR A COUPLE HOURS. THE PATIENT PROGRAMMER WAS REPORTEDLY SHOWING A ¿CALL YOU DOCTOR¿ ICON. IT WAS NOTED THAT THE PATIENT PROGRAMMER DISPLAYED THE ¿SPLASH¿ SCREEN WHEN POWERING ON, THE PATIENT CHANGED THE BATTERIES IN THE PATIENT PROGRAMMER THE PATIENT WAS ABLE TO SYNC WITH THE IMPLANTED DEVICE AND TURN IT BACK ON. IT WAS FURTHER NOTED THAT THE PATIENT COULD FEEL STIMULATION AND THAT THE PATIENT WAS ON PROGRAM C, AND IMPLANTED DEVICE BATTERY LEVEL SHOWED 3/4 FULL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE IMPLANT DIED. IT WAS REPORTED THE DEVICE WOULD NOT TAKE A CHARGE. IT WAS REPORTED THE PATIENT WAS HAVING DIFFICULTY TURNING THEIR STIMULATOR OFF.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT WAS WORKING WITH THEIR HEALTHCARE PROFESSIONAL OR MANUFACTURING REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT WAS WAITING FOR THE DOCTOR TO CALL BACK WITH AN APPOINTMENT DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260429 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR