BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2883953 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12170
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    December 3, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION DEVICE WAS USED FOR WAS GZF OR MOTOR CORTEX STIMULATION. IT WAS UNCLEAR WHICH THERAPY THE DEVICE WAS USED FOR. PRODUCT ID 748940, SERIAL# (B)(4), PRODUCT TYPE EXTENSION, PRODUCT ID 748940, SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID 7434A, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7434A, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3587A25, LOT# N153791, PRODUCT TYPE LEAD, PRODUCT ID 3587A25, LOT# N153791, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE BOTTOM LINE WAS THAT THE SYSTEM WAS WORKING AS DESIGNED AND THERE WERE NO IMPEDANCE ISSUES. THE PATIENT'S HEALTHCARE PROVIDER (HCP) KEPT TRYING TO WORK WITH THE DEVICE, LOWERING THE PATIENT'S PULSE WIDTH AND PUTTING HER AT A HIGHER RATE WITH NO EFFECT. AS SUCH, IT WASN'T CERTAIN WHAT THE NEXT PLAN OF ACTION WOULD BE. THE REPORTER INDICATED THAT THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT LATER THAT DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT THREE YEARS AGO BOTH OF A PATIENT'S STIMULATORS WERE TOO HIGH AND CAUSED HER TO GO INTO A SEIZURE. THE RE PORTER STATED THAT THE PATIENT'S MOTOR CORTEX STIMULATION AT THE TIME OF THE SEIZURE WAS SET TO THE HIGHEST SETTING OF 9.0 AMP. IT WAS REPORTED THAT THE SEIZURE STOPPED WHEN THE PATIENT'S HUSBAND TURNED OFF BOTH STIMULATORS. THE NEXT DAY, IT WAS REPORTED THAT THE PATIENT WOULD MANIPULATE THE TWO SYSTEMS TO "ATTACK" WHEN SHE GOT SEIZURES. THE REPORTER STATED THAT SHE HAD "DEVELOPED HER OWN APPROACH," BUT THE SEIZURES WERE OCCURRING MORE OFTEN AND WERE STRONGER. IT WAS UNCLEAR IF THE PATIENT HAD HAD MORE THAN ONE SEIZURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 Other