BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3000297 · Received March 12, 2013

    Report

    Report Number
    3004209178-2013-03601
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 23, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65 LOT# SERIAL# V(B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION IS TURNED ON, STIMULATION WILL "JUST STOP FOR 5 MINUTES OR SO." THIS WOULD OCCUR WHEN THE PATIENT WAS LAYING DOWN AND NOT MOVING. IT WAS ASKED WHETHER OR NOT THE PROGRAMMER COULD TELL IF THE LEAD HAD MOVED. IT WAS ALSO REPORTED, THE PATIENT HAD A SPOT ON HIS LEFT LEG THAT COULD NOT GET ANY THERAPY. THE PATIENT WAS "UNSURE IF HE HAD NERVE DAMAGE THERE OR NOT." 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 THAT AT DATE OF REPORT PATIENT WAS GOING TO GET A ¿STEROID INJECTION LATER ON IN THE NEXT MONTH.¿ IT WAS FURTHER REPORTED THAT PATIENT GOT ELECTROCUTED AT DATE OF REPORT. PATIENT REPORTED THAT HE FELT ¿VERY UNCOMFORTABLE¿ DUE TO HIS DEVICE. PATIENT STATED AT DATE OF REPORT THAT WHEN SLEEPING HE WOKE UP EVERY TWO HOURS ¿FEELING LIKE I¿M BEING ELECTROCUTED." IT WAS FURTHER REPORTED THAT AN X-RAY WAS ORDERED FOR THE PATIENT ¿TO SEE IF THE LEAD HAD MOVED BECAUSE WE¿RE NOT ABLE TO MAKE THE ADJUSTMENTS I NEED.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD TO HAVE THE ACCELEROMETER FOR THE ADAPTIVE STIM (AS) FEATURE REPROGRAMMED ON (B)(6) 2013 AS IT ¿WASN¿T WORKING AT ALL.¿ IT WAS REPORTED THE PATIENT PROGRAMMER DISPLAYED A ¿WEIRD SCREEN¿ WHERE AFTER AS WAS REPROGRAMMED, THE CONTROLLER WORKED NORMALLY AGAIN. IT WAS STATED THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULD TURN OFF FOR 20-30 MINUTES AND THEN IT WOULD KICK BACK ON FOR NO REASON. APPROXIMATELY 5 DAYS AFTER REPROGRAMMING IT WAS STATED THE PROBLEM WAS STILL OCCURRING. IT WAS REPORTED THE PATIENT WAS DRIVING IN THEIR CAR AND STIMULATION "JUST STOPPED" FOR 25 MINUTES THEN KICKED BACK ON. THIS ISSUE HAD BEEN OCCURRING OFF AND ON SINCE (B)(6) 2013. IT WAS REPORTED THE PATIENT HAD A ¿MYONAGRAM¿ WHERE THEY ¿FLIP THEM UPSIDE DOWN.¿ FOR THE PROCEDURE, WHEN THE PATIENT WAS ¿FLIPPED UPSIDE DOWN,¿ THE STIMULATOR ¿WENT (B)(6) BECAUSE THEY HAD IT TURNED ON STILL.¿ IT WAS STATED THE TEST WAS DONE ¿ABOUT A MONTH¿ PRIOR TO THIS REPORT, AND IT HAD NOT BEEN THE SAME SINCE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS CHARGING MORE THAN EXPECTED. THE PATIENT COULDN¿T CHARGE PAST 75% FULL AND WAS HAVING A HARD TIME RECHARGING. IT WAS NOTED THE PATIENT HAD LOST 50 POUNDS SINCE IMPLANT. RECHARGE STATISTICS NOTED SHORT SESSIONS AND 2-4 COUPLING BARS. IT WAS STATED THE PATIENT WAS LOSING STIMULATION SENSATION THAT WOULD COME BACK AFTER 2 MINUTES, AND SOMETIMES COME BACK AFTER 30 MINUTES. THIS COULD REPORTEDLY OCCUR WHILE WALKING, UPRIGHT TO SITTING, OR LAYING DOWN. THE REPORTER WOULD NOT DO ANYTHING TO MAKE IT COME BACK, IT WOULD RETURN ON ITS OWN. IT WAS REPORTED THAT THE MANUFACTURING REPRESENTATIVE WOULD RE-ORIENT THE DEVICE TO SEE IF IT HELPED WITH THE LOSS OF STIMULATION PERCEPTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT SOMETIMES DEVICE WOULD ¿COME BACK ON PERIODICALLY¿ AFTER IT STOPPED. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT¿S DEVICE WAS TOO ¿HIGH¿ IN HIS BACK. IT WAS NOTED THE HEALTH CARE PROVIDER WANTED TO ¿PUT A DIFFERENT ONE IN LOWER.¿

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED THAT THE PATIENT'S "RECEIVER" DID NOT WORK. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LIGHTNING BOLT WAS ON BUT THE PATIENT HAD NOT FELT ANYTHING FOR TWO DAYS SINCE THE DAY OF THE REPORT. THE PATIENT WAS IN THE HOSPITAL FOR PAIN AND ANOTHER CONDITION BUT IT WAS UNSURE IF THE PATIENT WAS ADMITTED OR NOT. THE REPORTER INDICATED THAT THE PATIENT "DIDN¿T HAVE ANYTHING" FOR PAIN MEDICATIONS AND HIS DEVICE WAS NOT WORKING. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013. THE REPORTER STATED THE PATIENT HAD BEEN ELECTROCUTED AND SHOCKED WHEN HE ¿MOVED OR CHANGED¿ AND THIS HAD BEEN GOING ON FOR 3 MONTHS. IT WAS NOTED THAT THE PATIENT'S SETTINGS HAD BEEN RE-ADJUSTED ¿MULTIPLE TIMES¿ AND THE LAST TIME WAS 4 WEEKS PRIOR TO THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103889 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