BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1021074 · Received March 27, 2008

    Report

    Report Number
    2029203-2008-00161
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE DISCARDED LEAD WAS COMPLETED AND NO ANOMALIES WERE NOTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    DURING THE TRIAL LEAD IMPLANT PROCEDURE THE PATIENT'S DURA WAS PUNCTURED BY THE INSERTION NEEDLE. THE PROCEDURE WAS ABORTED. THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LEAD LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2138-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention