BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3538351 · Received December 26, 2013

    Report

    Report Number
    3004209178-2013-24047
    Event Type
    Malfunction
    Date Received
    December 26, 2013
    Report Date
    December 10, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3986A, LOT# N202582, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. IT WAS NOTED THAT THE PATIENT COULD NOT GET THE BOX TO WORK. IT WAS NOTED THAT THE PATIENT COULD NOT TELL IF IT WAS HIGH OR LOW. IT WAS NOTED THAT THE PATIENT WAS NOT FEELING STIMULATION. IT WAS NOTED THAT THE UPPER LIMIT WAS REACHED AND THE PATIENT WAS NOT ABLE TO GO ABOVE 5.0 VOLTS. IT WAS NOTED THAT FOR THE PAST MONTH THE PATIENT HAD FELT NO STIMULATION. IT WAS NOTED THAT THE PATIENT COULD NOT FEEL STIMULATION AT THE CURRENT SETTING AND ONLY HAD ONE GROUP PROGRAMMED ON THE DEVICE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT IT WAS NOT WORKING. IT WAS NOTED THAT THEY COULD INTERROGATE WITH NO ISSUES AND THE BATTERY VOLTAGE WAS GOOD. IT WAS NOTED THAT THE PATIENT DID NOT HAVE A MANAGING PHYSICIAN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD LOOKED LIKE IT WAS FINE. IT WAS NOTED THAT ELECTRODE IMPEDANCES WERE RANGED FROM 1200 TO 2000 OHMS. IT WAS NOTED THAT THE THERAPY IMPEDANCE WAS 5.0V, 50 HERTZ, 90 MICROSECONDS, AT 554 OHMS AND 8.886 MILLIAMPS OF CURRENT. IT WAS NOTED THAT ALL ELECTRODES WERE ACTIVE. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE WOULD NOT REPROGRAM BECAUSE THE PATIENT HAD IMPLANT FOR MOTOR CORTEX. IT WAS NOTED THAT THE PATIENT WAS IN EXTREME PAIN ON THE LEFT SIDE. IT WAS NOTED THAT LAST WEEK THE PATIENT WENT TO THE EMERGENCY ROOM BECAUSE OF THIS. IT WAS NOTED THAT THE STIMULATOR USED TO HELP TREMENDOUSLY BUT NOW IT DID NOT SEEM TO BE HELPING. IT WAS NOTED THAT THE PATIENT DID NOT FEEL STIMULATION. IT WAS NOTED THAT THE PATIENT DID NOT NOTICE ANY STIMULATION RELATED SIDE EFFECTS. IT WAS NOTED THAT THE SYMPTOMS HAD BEEN RETURNING OVER THE PAST TWO MONTHS. IT WAS NOTED THAT THE PATIENT THOUGHT THAT THEY WOULD NEED TO GO BACK TO THE EMERGENCY ROOM BECAUSE OF THE PAIN. IT WAS NOTED THAT THERE WAS NO REPORT OF POCKET STIMULATION OR PARESTHESIAS. IT WAS NOTED THAT THERE WAS JUST INCREASED PAIN OF THE LEFT SIDE. IT WAS NOTED THAT THE PATIENT STATED TO FEEL PAIN FOLLOWING A KNEE SURGERY TWO MONTHS AGO AND SINCE THEN IT HAD BEEN A DOWNHILL SLIDE. IT WAS NOTED THAT FURTHER TROUBLESHOOTING DETERMINED THAT THE PATIENT¿S IMPLANT WAS OFF. IT WAS NOTED THAT THEY WERE UNSURE WHEN THE DEVICE WAS LAST ON. IT WAS NOTED THAT THEY DECIDED TO TURN THE IMPLANT BACK ON AND SEE IF THE SYMPTOMS RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675989 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR