BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3853155 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10241
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    May 13, 2014
    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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-8, LOT# N307737, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 8590-8, LOT# N300513, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT ASKED TO HAVE THEIR PROGRAMMING SET TO THE ORIGINAL SETTINGS. THE MANUFACTURER¿S REPRESENTATIVE RESET THE PATIENT¿S SETTINGS ON THEIR INS TO WHICH THEY HAD FOR THE PREVIOUS 2 YEARS. THE PATIENT RECENTLY COMPLAINED AFTER THESE APPOINTMENTS ABOUT ¿POSITIONAL¿ OVERSTIMULATION SO IT WAS REVIEWED WITH THEM HOW THE DEVICE WORKED AND ITS LIMITATIONS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THAT THERAPY WAS NOT WORKING AS EXPECTED. THE CALLER STATED THAT THE PATIENT HAD AN ADJUSTMENT ONE DAY PRIOR TO REPORT FOR THE FIRST TIME IN TWO YEARS. THE CALLER STATED THAT WHEN THE PATIENT GOT HOME AND LAY DOWN ON THE BED THEY WERE ¿JOLTED.¿ THE CALLER STATED THAT THE PATIENT HAD THE CALLER TURN STIMULATION OFF, THE PATIENT HAD STIMULATION TURNED OFF, AND HAD A ¿SEVERE¿ HEADACHE ¿BECAUSE OF IT.¿ THE CALLER STATED THAT THE PATIENT NOW HAD A ¿REALLY BAD¿ HEADACHE. THE CALLER STATED THAT THEY SET UP AN APPOINTMENT BUT THE MANUFACTURER REPRESENTATIVE WAS NOT ABLE TO SEE THE PATIENT FOR TWO DAYS. THE CALLER DID NOT THINK ¿THIS¿ WAS ACCEPTABLE. THE CALLER ¿DID NOT THINK THE PATIENT COULD WAIT TWO DAYS.¿ THE CALLER WANTED TO MEET WITH A MANUFACTURER REPRESENTATIVE FOR A DEVICE CHECK AND PROGRAMMING. PATIENT SERVICES OFFERED TO WALK THE CALL ER THROUGH STEPS TO TURN STIMULATION DOWN INSTEAD OF ONLY OFF AND THE CALLER REFUSED. IT WAS LATER REPORTED THAT THE MANUFACTURER REPRESENTATIVE HAD AN APPOINTMENT WITH THE PATIENT AT 3 PM ON (B)(6) 2014. IT WAS LATER REPORTED THAT THE MANUFACTURER REPRESENTATIVE PROGRAMMED THE PATIENT ¿LAST WEEK¿ AND THE PATIENT DID NOT GET PAIN RELIEF. THE CALLER NOTED THAT THEY ATTEMPTED TO REACH THE MANUFACTURER REPRESENTATIVE FOR FURTHER PROGRAMMING. IT WAS LATER REPORTED ON (B)(6) 2014 THAT THE MANUFACTURER REPRESENTATIVE ¿WIPED OUT¿ THE PATIENT¿S PREVIOUS SETTINGS AND STARTED ENTERING PROGRAMS. IT WAS NOTED THAT THE PATIENT WAS PROGRAMMED THREE TIMES AND ¿STILL DID NOT HAVE PAIN RELIEF.¿ IT WAS NOTED THAT THE PATIENT HAD THERAPY TURNED OFF. IT WAS NOTED THAT THE PATIENT STARTED TO NOT GET ENOUGH PAIN RELIEF THREE MONTHS PRIOR TO (B)(6) 2014. IT WAS FURTHER NOTED THAT STIMULATION WAS NEEDED IN THE PATIENT¿S LEFT LEG, KNEE AND FOOT. IT WAS NOTED THAT BECAUSE PROGRAMMING DID NOT RELIEVE THE PAIN THEY HAD TURNED THERAPY OFF. THE PATIENT ALSO NOTED THAT ADAPTIVE STIMULATION ¿HAD NOT WORKED¿ SINCE ¿SATURDAY.¿ THE PATIENT WAS TAKING PERCOCET AND OXYCONTIN FOR PAIN RELIEF. IT WAS NOTED THAT THE CALLER CONTACTED THE MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE ¿LAST FRIDAY.¿ THE FAMILY MEMBER WANTED A RETURN CALL. THE PATIENT¿S STATUS WAS UNKNOWN. IT WAS LATER REPORTED ON (B)(6) 2014 THAT THE MANUFACTURER REPRESENTATIVE HAD PROGRAMMED THE PATIENT THREE TIMES WITHIN THE ¿LAST FEW¿ WEEKS. IT WAS NOTED THAT WHEN THE PATIENT FIRST CAME IN THE PATIENT STATED THAT THEY HAD NOT BEEN CHECKED IN TWO YEARS AND THE THERAPY HAD NOT BEEN WORKING. IT WAS NOTED THAT THE PATIENT WANTED MORE THERAPY ON THE LEGS AND BUTTOCKS. THE PATIENT STATED THAT THE BUTTOCKS AND LEG HURT AND WAS NOT ¿GETTING ANY THERAPY THERE.¿ AS A RESULT THE MANUFACTURER REPRESENTATIVE PROGRAMMED THE PATIENT. IT WAS NOTED THAT THE PATIENT WAS SET UP FOR PROGRAMMING WHICH WAS ¿MUCH HIGHER UP¿ IN THE ¿SPINE AREA¿ AND WAS CAUSING STIMULATION IN THE SPINE AND ABDOMEN. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE WAS ABLE TO FIX THE ISSUE. THE PATIENT WAS SENT HOME. THE PATIENT CALLED AND STATED THAT THEY HAD DISCOMFORT AND SO THE MANUFACTURER REPRESENTATIVE SET UP A SECOND APPOINTMENT AND PROGRAMMED THE PATIENT AGAIN. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE MADE SURE ¿ALL OF THE SENSOR STUFF WAS WORKING RIGHT.¿ THE PATIENT WAS HAPPY. A COUPLE DAYS LATER, THE PATIENT WANTED THE MANUFACTURER REPRESENTATIVE TO ¿TWEAK [THE PATIENT] SOME MORE¿ BECAUSE THEY STILL HAD DISCOMFORT. AS A RESULT, THE MANUFACTURER REPRESENTATIVE PROGRAMMED ¿SOME MORE.¿ IT WAS NOTED THAT THE PATIENT AGAIN LEFT HAPPY AND SAID EVERYTHING WAS FINE. THE MANUFACTURER REPRESENTATIVE NOTED THAT THE INS WAS PUT IN THE ¿BUTT CHEEK¿ AND THE MANUFACTURER REPRESENTATIVE THOUGHT WHAT WAS HAPPENING WAS THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) ITSELF HAD A HARD TIME DIFFERENTIATING BETWEEN SITTING AND LAYING BACK. THE MANUFACTURER REPRESENTATIVE EXPLAINED TO THE PATIENT BECAUSE ¿THEY¿ PUT THE GENERATOR ¿SO LOW¿ THE INS ¿WAS NOT REALLY SENSING ANY CHANGE IN POSITION.¿ IT WAS NOTED THAT IF IT WAS SET FOR SITTING AND THE PATIENT LAID BACK THEY FELT TOO MUCH STIMULATION. THE MANUFACTURER REPRESENTATIVE THOUGHT THAT ¿MOST OF THE PROBLEM¿ WAS THAT THE SENSOR WAS PUT IN THE ¿BUTT CHEEK¿ AND NOT IN THE LOWER BACK AND THAT CAUSED THE INS NOT TO SENSE CHANGE. THE MANUFACTURER REPRESENTATIVE STATED THAT THE PATIENT CALLED AGAIN ON MONDAY AND THE MANUFACTURER REPRESENTATIVE TOLD THE PATIENT THAT THEY WOULD TRY TO SEE THE PATIENT AGAIN. THE MANUFACTURER REPRESENTATIVE THOUGHT THAT AN APPOINTMENT WAS SET UP FOR (B)(6) 2014. THE MANUFACTURER REPRESENTATIVE STATED THAT THEY WERE A GOOD PROGRAMMING AND HAD GOOD THERAPY IN THE PATIENT¿S LEGS. HOWEVER, WHEN THE PATIENT LEANED BACK THEY WERE GETTING OVERSTIMULATION BECAUSE THE INS WAS NOT SENSING CHANGE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331981 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