BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2852994 · Received November 30, 2012

    Report

    Report Number
    3004209178-2012-10990
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 2, 2012
    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

    PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3587A25, LOT# N169339, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    AN OVERSTIMULATION SENSATION WAS REPORTED. THE NEUROSTIMULATOR WAS USED FOR MOTOR CORTEX STIMULATION FOR FACIAL/TRIGEMINAL PAIN. IT HAD BEEN SUCCESSFULLY USED DAILY, UNTIL THE PATIENT "TURNED ON HER SYSTEM ON (B)(6) 2012, THE DAY OF (B)(6)" AT HER USUAL SETTING OF 8.5V AMPLITUDE BUT IT FELT SO STRONG THAT "IT SEEMED LIKE A SEIZURE." THE SENSATION WAS NOT A PARESTHESIA, BUT "SEIZURE-LIKE." THE SYMPTOMS WERE DESCRIBED AS MOTOR ACTIVITY IN UPPER LIMBS, FACE AND SHOULDER. THE DEVICE WAS TURNED OFF AND THE SENSATION DISSIPATED IN ABOUT 10-15 MIN. SHE WAS NOT CONSIDERED TO BE INJURED. UPON TROUBLESHOOTING AT HER DOCTOR'S OFFICE ON (B)(6) 2012, ALL IMPEDANCES WERE DEEMED "EXCELLENT" AND BATTERY WAS "GOOD." THE AMPLITUDE WAS LOWERED FROM PATIENT'S USUAL 8.5V TO 5V, THE DEVICE WAS TURNED ON, AND THE AMPLITUDE WAS RAISED SLOWLY TO 7.0V AT WHICH POINT SHE WAS UNEASY GOING ANY HIGHER, DESPITE NOT FEELING ANY SENSATION, GOOD OR BAD. SHE WAS CONTENT FOR IT TO OPERATE IT AT WHAT SHE FELT WAS A LOW THRESHOLD LEVEL AND "LEFT IT THERE." THE PATIENT HAD FOUND THE SYSTEM TO BE VERY HELPFUL, BUT WAS NOW LEERY. THE PATIENT WAS HAPPY TO CONTINUE USING THE DEVICE AT A REDUCED LEVEL. ON (B)(6) 2012, THE PATIENT WAS READY TO USE HER DEVICE AGAIN SINCE HER PAIN HAD RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1