BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1312320 · Received February 12, 2009

    Report

    Report Number
    2029203-2009-00289
    Event Type
    Injury
    Date Received
    February 12, 2009
    Date of Event
    August 1, 2007
    Report Date
    January 14, 2009
    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
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE PATIENT WENT IN FOR A LEAD REVISION PROCEDURE AND FOLLOWING THE EVENT; THE PATIENT DEVELOPED A MRSA INFECTION AND HAD TO HAVE THE SYSTEM EXPLANTED. THE PATIENT WAS HOSPITALIZED AND RECEIVED ANTIBIOTICS FOR EIGHT WEEKS. THE PATIENT STATES THE INFECTION WAS NOT DEVICE RELATED.

    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 52 YR Hospitalization| R LINEAR LEAD (PHASE IIIA)| LEAD EXTENSION| MODEL# SC-3138-35| LINEAR LEAD