BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3830094 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09558
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    November 17, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO LONGER APPLY. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE INS GOES ON/OFF FOR NO APPARENT REASON. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE EVENT STARTED ¿FOR THE PAST COUPLE WEEKS¿. THE PATIENT DID NOT REMEMBER A SPECIFIC EVENT THAT MIGHT HAVE IMPACTED THE SPINAL CORD STIMULATION (SCS), ¿THE ONLY THING I CAN THINK OF IS I LET THE BATTERY GO COMPLETELY DEAD AND HAD TO RECHARGE. FOR THE PAST MONTH I¿VE BEEN TAKING CARE OF MY ELDERLY PARENTS, SO I¿M DOING MORE ACTIVITY THAN I NORMALLY DO BECAUSE I¿M DISABLED, BUT DON¿T KNOW IF THAT WOULD HAVE CAUSED IT¿. IT WAS ALSO STATED ¿MY DEVICE IS ACTING STRANGE. TURNS ON, THEN SHUTS OFF, NOT AS A RESULT OF A MOVEMENT. ON/OFF FOR NO APPARENT REASON. IT¿S FULLY CHARGED AND SOME OF THE SETTINGS HAVE BEEN DELETED OUT OF THE SYSTEM SOMEHOW¿. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THEY NOTIFIED THE MANUFACTURER THAT IN CERTAIN POSITIONS, FOR EXAMPLE WHEN THEY WERE STANDING AND TOOK 2 STEPS, IT FELT LIKE THE UNIT WENT COMPLETELY OFF OR WENT FROM HIGH TO SO LOW THAT THEY COULDN¿T FEEL IT. IT WAS NOTED THAT THE PATIENT WAS NOW WITH A NEW PAIN DOCTOR AND SCHEDULED AN APPOINTMENT WITH A SURGEON BECAUSE THE PROBLEM THAT IT SEEMED TO GO OFF AND FOLLOWING THAT PROBLEM THEY TRIED TO REPROGRAM SEVERAL TIMES AND THEY STILL HAD THE PROBLEM SO THE PATIENT MADE THE DECISION TO REPLACE THE UNIT. IT WAS NOTED THEY WERE TRYING TO MAKE A DECISION ABOUT WHAT OTHER SPINAL CORD STIMULATION (SCS) DEVICES WERE AVAILABLE BECAUSE THEIR CURRENT DEVICE HAD ADAPTIVE STIMULATION AND THE CONSTANT ADJUSTING WAS WHERE THEY WERE RUNNING INTO PROBLEMS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S THERAPY AND CHARGING WERE ADEQUATE. THE REPORTER STATED THEY REVIEWED HOW TO CHANGE VOLTAGE FOR A POSITION AND STAY FOR THREE MINUTES TO HAVE THE BATTERY REMEMBER THE SETTING FOR EACH POSITION. IT WAS NOTED THE PATIENT HAD ACCIDENTALLY SET UPRIGHT VOLTAGE TO THE SAME AS LYING DOWN VOLTAGE. IT WAS FURTHER NOTED THE PATIENT THOUGHT THEIR STIMULATOR WAS SHUTTING OFF WHEN THEY JUST HAD THE VOLTAGE TOO LOW. THE REPORTER STATED THAT EVERYTHING WAS WORKING AND THE PATIENT HAD ADEQUATE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308814 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 00052 YR