BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 5988999 · Received September 29, 2016

    Report

    Report Number
    3006630150-2016-02748
    Event Type
    Injury
    Date Received
    September 29, 2016
    Date of Event
    September 13, 2016
    Report Date
    December 14, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2366-30, SERIAL: (B)(4), DESCRIPTION: LINEAR 3-6 LEAD, 30CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DURA PUNCTURE CAUSING A CEREBRAL SPINAL FLUID LEAK OCCURRED DURING THE INSERTION OF THE NEW LEAD. MEDICATION WAS ALSO ADMINISTERED AND THE EVENT RESOLVED ON (B)(6) 2016. THE EVENT WAS ASSESSED AS BEING RELATED TO THE SURGICAL PROCEDURE AND DEVICE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EPIDURAL BLOOD PATCH DUE TO A DURA PUNCTURE. THE PATIENT HAD BEEN EXPERIENCING A HEADACHE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EPIDURAL BLOOD PATCH DUE TO A DURA PUNCTURE. THE PATIENT HAD BEEN EXPERIENCING A HEADACHE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A LEAD IMPLANT PROCEDURE THE PATIENT EXPERIENCED A DURA PUNCTURE AND UNDERWENT AN EPIDURAL BLOOD PATCH PROCEDURE. THE PATIENT HAD BEEN EXPERIENCING A HEADACHE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638094 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R