BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3863998 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11287
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 20, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED IN (B)(6). THE PATIENT HAD GREAT COVERAGE AND ACTIVATED ADAPTIVE STIMULATION. STARTING ON WEDNESDAY DURING THE WEEK PRIOR TO THE REPORT THE PATIENT WAS SITTING IN THEIR TRUCK AND THEIR PROGRAMMER SAID THEY WERE LYING BACK WHEN THEY WERE SITTING. IT ALSO SHOWED THAT THEY WERE MOBILE WHEN THEY WERE SITTING. THESE ISSUES WERE HAPPENING EVERYWHERE. THE DEVICE WAS TURNING UP REALLY HIGH AND THE MANUFACTURER REPRESENTATIVE THOUGHT THAT IT WAS RECOGNIZING A DIFFERENT POSITION AND GETTING TO THAT VOLTAGE. THE IMPEDANCES WERE ALL GOOD FROM 900-1070 OHMS. THE PATIENT CAUGHT THEIR DAD FROM FALLING ON (B)(6) PRIOR TO THE REPORT. IT WAS FURTHER REPORTED THAT THERE WAS NO DIAGNOSTIC TEST RUN. THE PATIENT¿S BATTERY WAS REORIENTED AND THEIR ADAPTIVE STIMULATION AND AMPLITUDES WERE SET FOR THEM IN EACH POSITION. ON THE MORNING OF THE REPORT EVERYTHING WAS WORKING GREAT AND THE PATIENT WAS HAVING NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339139 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