BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6011620 · Received October 7, 2016

    Report

    Report Number
    3004209178-2016-21322
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    August 26, 2016
    Report Date
    May 30, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THERE WERE ISSUES WITH STIMULATION AFTER PHYSICAL THERAPY SESSIONS. THE PATIENT HAD A MOTOR VEHICLE ACCIDENT, BUT WAS FINE AFTER THE ACCIDENT. THE ISSUES DID NOT START UNTIL AFTER THE PHYSICAL THERAPY SESSIONS BEGAN. THE ISSUE IS NOT RELATED TO POSITIONAL MOVEMENT. THE PATIENT HAS AN APPOINTMENT ON (B)(6) 2016 TO HAVE THE IMPLANTABLE NEUROSTIMULATOR CHECKED AS WELL AS THE LEADS TO MAKE SURE THAT THERE ARE NO DEVICE ISSUES. THE STIMULATION WAS NO LONGER GOING ALL THE WAY DOWN HIS LEG AND HE ONLY FEELS IT IN THE LOWER BACK AND HIP. THE STIMULATION FEELS DIFFERENT NOW. THIS STARTED OCCURRING SUDDENLY WHEN HE HAD BEEN GETTING STIMULATION AT PHYSICAL THERAPY. HIS IMPLANTABLE NEUROSTIMULATOR WAS DEAD AFTER THE APPOINTMENT, EVEN THOUGH IT WAS AT 100% BEFORE THE APPOINTMENT. THE PATIENT ALSO HAS TO CHARGE TWICE A WEEK NOW VERSUS ONCE A WEEK PRIOR TO STARTING PHYSICAL THERAPY. THE PATIENT ALSO HAS THIGH PAIN NOW SINCE STARTING PHYSICAL THERAPY. THIS STARTED OCCURRING ABOUT TWO WEEKS PRIOR TO THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED BY A CONSUMER ON 2017-OCT-10 THAT THE PATIENT HAD AN MRI TO CHECK ON A SUSPECTED PROBLEM WITH THEIR DEVICE OR THERAPY. PER THE CONSUMER, THEY HAD BEEN TOLD THAT THEY WERE UNABLE TO DO AN MRI. THE PATIENT PROGRAMMER WAS NOT AVAILABLE TO THE CONSUMER DURING THE CALL TO DETERMINE MRI ELIGIBILITY. THE PATIENT STATED THAT THEY THOUGHT THAT THEY NEEDED BACK SURGERY AND FELT LIKE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) MAY HAVE MOVED OUT OF PLACE DUE TO A CAR WRECK. THE CAR WRECK WAS IN AUGUST AND THEIR ISSUES HAD BEEN SINCE THEN. THE ¿PROBLEM¿ WAS CLARIFIED TO BE THAT THEIR INS HAD BEEN GOING OFF AND ON AND THEIR BACK WAS HURTING WHERE THE INS WAS. THE PATIENT HAD A RESET PERFORMED BY A MANUFACTURER REPRESENTATIVE. THE ISSUES WERE CONFIRMED TO HAVE STARTED ON (B)(6) 2016. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE ON 2017-NOV-06 AND 2017-NOV-07 REPORTING THAT THEY HAD NOT BEEN MADE AWARE OF STIMULATION TURNING ON AND OFF. ANOTHER MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT MULTIPLE TIME TO WORK IN CHARGING THE DEVICE. THE PATIENT DID NOT CHARGE THE BATTERY AFTER THE FIRST VISIT WHICH REQUIRED A FOLLOW-UP TO GET THE BATTERY CHARGED AND RUNNING. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE PATIENT REPORTED THAT HE WAS IN A CAR ACCIDENT AND THEY WOULD LIKE TO DO AN MRI TO CHECK THE NEUROSTIMULATOR (INS) AND SEE IF IT HAD MOVED. THE PATIENT REPORTED THAT HE HAD A CHANGE IN THERAPY FOLLOWING THIS CAR WRECK. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661541 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97712

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR