BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3944227 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13235
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POR (POWER ON RESET) CONDITION OCCURRED. IT WAS REPORTED THAT THE ERROR CODE WAS 0X400. IT WAS STATED THAT THE PATIENT DID NOT REMEMBER BEING AROUND EMI (ELECTROMAGNETIC INTERFERENCE), BUT IT WAS FURTHER STATED THAT THE PATIENT FLEW TWO TIMES IN MAY. IT WAS REPORTED THAT A COUPLE WEEKS AGO THE PATIENT WAS TRYING TO CHARGE AND IT WAS NOT CHARGING PROPERLY. IT WAS STATED THAT THE RECHARGER SHUT OFF AND THEN THE PATIENT SAW THE ERROR CODE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE POR (POWER ON RESET) WAS CLEARED. IT WAS REPORTED THAT THE PATIENT WAS ABLE TO CHARGE HER DEVICE AS IT WAS CHECKED BEFORE THEY LEFT THE OFFICE. IT WAS NOTED THAT AFTER HANGING UP WITH TECH SERVICES, THE PATIENT STATED THAT SHE HAD BEEN USING HER ELECTRIC BLANKET A LOT AND WONDERED IF THIS COULD HAVE BEEN THE EMI THAT CAUSED THE POR, AS SHE HAD NO DIAGNOSTIC TESTS THAT WOULD HAVE CAUSED IT. IT WAS STATED THAT THE SENSOR WAS ACTIVATED PRIOR TO LEAVING THE OFFICE. IT WAS REPORTED THAT THE PATIENT WAS HAPPY WITH THE DEVICE AND SERVICE WHEN SHE LEFT THE APPOINTMENT. IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE HAD NOT HEARD FROM THE PATIENT SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422561 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR