BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL

    MDR report key: 2190403 · Received July 25, 2011

    Report

    Report Number
    3007566237-2011-05760
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    August 1, 2010
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    K903690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE END OF THE TRIAL PERIOD, REMOVAL OF THE TRIAL LEADS CAUSED THE PATIENT'S L1-S5 DISC TO "BURST." THE PATIENT HAD BEEN LEANING OVER A CHAIR AND FELT A PAINFUL "RIPPING OR JERKING" OF THE LEADS UPON REMOVAL. FOLLOWING REMOVAL THE PAIN INCREASED, AND THE PATIENT WAS ALLOWED TO INCREASE THE DOSAGE OF ORAL PAIN MEDICATION. THE PATIENT CONTINUED TO EXPERIENCE PAIN AND PRESENTED TO THE ER ON (B)(6) 2011 WHEN THE PAIN BECAME EXCRUCIATING. THE PATIENT WAS HOSPITALIZED FOR APPROXIMATELY (B)(6), ONE OF WHICH WAS IN THE ICU, AND HAD EMERGENCY SURGERY TO REMOVE THE DISC. THE PATIENT WAS PARALYZED IN THE RIGHT FOOT OR LEG AND COULD ONLY AMBULATE WITH A WALKER. THE PATIENT STILL CONTINUED TO EXPERIENCE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL MHY/GZF/GZB MHY MEDTRONIC NEUROMODULATION 3625 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| UNK CONVERSION TYPE: MODEL LEAD QUAD,| IMPLANTED:| LOT# UNK