BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1892648 · Received November 3, 2010

    Report

    Report Number
    3006630150-2010-01880
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEADS AND EXTENSIONS WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS EXPLANTED DUE TO AN INFECTION AT THE POCKET AND LEAD SITES. THE PT'S SYMPTOMS INCLUDED FEVER, REDNESS, AND DRAINAGE. THE PHYSICIAN DID NOT FEEL THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PT WAS GIVEN ORAL ANTIBIOTICS AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention LEAD EXTENSION, 35 CM| SERIAL #: (B)(4)| MODEL #: SC-2352-50, SERIAL #: (B)(4)| SERIAL #: (B)(4)| MODEL #: SC-3138-35, SERIAL #: (B)(4)| LINEAR 3-4 LEAD 50CM