BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3031533 · Received April 2, 2013

    Report

    Report Number
    3006630150-2013-00598
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50 SERIAL #: (B)(4), DESCRIPTION: ST LINEAR LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A HEADACHE DUE TO CSF LEAK AFTER A LEAD REVISION (MFR REPORT #:3006630150-2013-00532). THE PHYSICIAN BELIEVED THAT THE EVENT WAS PROCEDURE RELATED. THE PHYSICIAN DID A BLOOD PATCH. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135261 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R