BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3551232 · Received January 3, 2014

    Report

    Report Number
    3004209178-2014-00141
    Event Type
    Malfunction
    Date Received
    January 3, 2014
    Report Date
    December 13, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FEELING STIMULATION WHEN LYING DOWN. IT WAS NOTED THE PATIENT WAS REPROGRAMMED ON (B)(6) 2013 SO WHEN THEY LIE DOWN THEY WOULD NOT FEEL STIMULATION AND WHEN SITTING UP THEY WOULD FELT STIMULATION AGAIN WITHIN FIVE SECONDS. THE REPORTER STATED THIS WAS NO LONGER WORKING AND THE PATIENT STILL FELT STIMULATION WHEN LYING DOWN. IT WAS NOTED THE PATIENT HAD NO KNOWN ACCIDENTS OR INCIDENTS RELATED TO THIS COMPLAINT. IT WAS FURTHER NOTED THE PATIENT SET THE LYING POSITION TO 0.00 TO REORIENT FOR LYING DOWN AND THIS RESOLVED THE ISSUE. THE REPORTER STATED THEY WANTED TO TURN THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF AT NIGHT IN ORDER TO SLEEP. IT WAS NOTED THE PATIENT MET WITH A MANUFACTURING REPRESENTATIVE ON 2013-12-05 AND THEY PROGRAMMED THE INS TO SHUT OFF WHEN THE PATIENT WOULD LIE DOWN AND THEN TURN BACK ON FIVE SECONDS AFTER GETTING UP. THE REPORTER STATED THIS WORKED WELL FOR ABOUT THREE DAYS. THE REPORTER FURTHER STATED THAT STIMULATION STAYED ON WHEN LYING DOWN RATHER THAN SHUTTING OFF. IT WAS NOTED THAT WHEN THE PATIENT WAS ¿UP ON THEIR ELBOWS¿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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3548 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR