BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1943774 · Received December 21, 2010

    Report

    Report Number
    3006630150-2010-02112
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 1, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES 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 PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO A NON-DEVICE RELATED INFECTION THAT SPREAD TO THE PATIENT'S POCKET SITE. THE PATIENT'S SYSTEMS INCLUDED REDNESS AND SWELLING AT THE POCKET SITE. THE PT WAS GIVEN IV AND 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 54 YR Hospitalization| R MODEL # SC-2218-50| SERIAL # (B)(4)| SERIAL # (B)(4)| ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET| (B)(4)