BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2930614 · Received January 28, 2013

    Report

    Report Number
    3006630150-2013-00128
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    December 29, 2012
    Report Date
    December 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD WITH PRELOADED ENHANCED STYLET - 70 CM; MODEL #: SC-4316, LOT #: 15650810, DESCRIPTION: CLIK ANCHOR.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD PINK FLUID DRAINING FROM THE IMPLANT SITE. THE PATIENT HAD INFECTION WHICH THE PHYSICIAN BELIEVED TO BE PROCEDURE RELATED. ANTIBIOTICS WERE GIVEN TO THE PATIENT. THE PATIENT WAS DOING WELL AND THE INFECTION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37989 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention