BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1833444 · Received September 9, 2010

    Report

    Report Number
    3006630150-2010-01469
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE NOT RELEASED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT THAT THE PATIENT'S SYSTEM WAS EXPLANTED DUE TO INFECTION AT THE POCKET SITE. THE PATIENT'S SYMPTOMS WERE REDNESS AND PUS. THE PATIENT WAS TREATED WITH INTRAVENOUS AND ORAL ANTIBIOTICS AND WAS DOING WELL AFTER THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention ARTISAN 2X8 PADDLE LEAD, 70 CM| SERIAL # - (B)(4)| MODEL # - SC-8116-70