BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1910599 · Received November 19, 2010

    Report

    Report Number
    3006630150-2010-01945
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    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 EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING THE TRIAL IMPLANT THE PT WAS EXPERIENCING A SEVERE HEADACHE WHEN SHE STOOD UP. THE PHYSICIAN WAS UNAWARE OF A DURA PUNCTURE DURING THE PROCEDURE, BUT CONFIRMED A DURA PUNCTURE OCCURRED DUE TO THE PT'S SYMPTOMS. AFTER THE TRIAL LEADS WERE PULLED AND THE PHYSICIAN PERFORMED A BLOOD PATCH THE PT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention