BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3971928 · Received July 31, 2014

    Report

    Report Number
    3006630150-2014-01695
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 16, 2013
    Report Date
    December 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8216-70, SERIAL/LOT #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE SYMPTOMS OF INFECTION INCLUDED REDNESS AND SORENESS AT THE MIDLINE INCISION SITE. THE PHYSICIAN DID NOT BELIEVE THAT THE INFECTION WAS PROCEDURE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN INFECTION. THE PHYSICIAN DID NOT BELIEVE THAT INFECTION WAS DEVICE RELATED. THE PATIENT WAS ADMITTED IN THE HOSPITAL AND WAS ADMINISTERED INTRAVENOUS VANCOMYCIN. THE PATIENT HAD A WASHOUT AND UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN INFECTION. THE PHYSICIAN DID NOT BELIEVE THAT INFECTION WAS DEVICE RELATED. THE PATIENT WAS ADMITTED IN THE HOSPITAL AND WAS ADMINISTERED INTRAVENOUS VANCOMYCIN. THE PATIENT HAD A WASHOUT AND UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446524 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R