BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3051469 · Received April 10, 2013

    Report

    Report Number
    3006630150-2013-00665
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #:SC-2366-50 SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR 3-6 LEAD, 50CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT UNDERGO A LEAD REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE DUE TO LEAD SITE DISCOMFORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE DUE TO LEAD SITE DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153736 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention