BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4060179 · Received September 4, 2014

    Report

    Report Number
    3006630150-2014-02002
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2208-50, SERIAL #: (B)(4), DESCRIPTION: ST LINEAR LEAD 50CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD NO ISSUES WITH THE DEVICE. IT WAS PHYSICIAN¿S PREFERENCE TO EXPLANT THE SYSTEM TO SWAP OUT WITH A NON-BSN SYSTEM. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR UNKNOWN REASON.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540579 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention