BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3528884 · Received December 19, 2013

    Report

    Report Number
    3004209178-2013-23798
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Report Date
    December 17, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3487A-33, LOT# V013723, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TURNED OFF HIS DEVICE 3 YEARS PRIOR. THE PATIENT HAD EXPERIENCED A JOLT WHEN HE MOVED A CERTAIN WAY, AND HE TURNED THE STIMULATION OFF DUE TO THIS. IF THE PATIENT MOVED IN OTHER WAYS, HE WOULDN¿T FEEL ANYTHING AT ALL. WHEN THE PATIENT WOULD BEND DOWN, HE WOULD FEEL A SURGE. IF HE MOVED HIS HEAD A CERTAIN WAY, THE STIMULATION WOULD SPEED UP. THE PATIENT MET WITH A COMPANY REPRESENTATIVE ABOUT 3 YEARS AGO. THE PATIENT WAS TOLD IT TOOK A WHILE FOR THE LEADS TO SETTLE IN. THE PATIENT ALSO STATED THAT WHEN THE STIMULATION WAS ON IT DIDN¿T HELP WITH THE PAIN. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666819 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 00056 YR