BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4112231 · Received September 23, 2014

    Report

    Report Number
    3006630150-2014-02159
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED TRIAL 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 WHILE THE PHYSICIAN WAS PLACING THE TRIAL LEAD DURING THE TRIAL PROCEDURE, THE PATIENT HAD A WET TAP AND HAD SOME PAIN ASSOCIATED WITH IT. THE PHYSICIAN ABORTED THE TRIAL AND EXPLANTED THE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY WITH NO HEADACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592465 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention