BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3760237 · Received April 19, 2014

    Report

    Report Number
    3006630150-2014-00847
    Event Type
    Injury
    Date Received
    April 19, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A PERMANENT IMPLANT PROCEDURE, THE PATIENT WAS NOTED TO HAVE CEREBROSPINAL FLUID LEAKAGE. THE PHYSICIAN BELIEVED THAT THE EVENT WAS NOT DEVICE RELATED BUT WAS PROCEDURE RELATED. BLOOD PATCH WAS DONE, AND THE LEAD WAS EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239086 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention