BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFY 5X6X5 LEAD

    MDR report key: 2190736 · Received July 26, 2011

    Report

    Report Number
    3007566237-2011-05781
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    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 DURING LEAD PLACEMENT, A CEREBROSPINAL FLUID (CSF) LEAK OCCURRED. THE PHYSICIAN USED FIBRIN GLUE TO SEAL THE LEAK. NO DEVICE MALFUNCTIONS WERE IDENTIFIED. THE PT RECOVERED FROM THE CSF LEAK AND DID NOT EXPERIENCE ANY SYMPTOMS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIFY 5X6X5 LEAD LGW MEDTRONIC NEUROMODULATION 39565 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention