BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2034043 · Received March 30, 2011

    Report

    Report Number
    3006630150-2011-00433
    Event Type
    Injury
    Date Received
    March 30, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-2218-50 (B)(4) DESCRIPTION: ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCHES STYLET. (B)(6). A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE EXPLANTED DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE POCKET SITE. THE PATIENT DEVELOPED REDNESS AND SWELLING AT THE IPG LOCATION. ALTHOUGH THE DATE THE INFECTION BEGAN IS NOT KNOWN THE PATIENT HAS BEEN TAKING DANCOMYCIN FOR TWO MONTHS. THE PHYSICIAN BELIEVES THE INFECTION WAS PROCEDURE RELATED. THE PATIENT IS 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 Required Intervention