BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2123964 · Received June 14, 2011

    Report

    Report Number
    3006630150-2011-00903
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 21, 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
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-2218-50E (B)(4) DESCRIPTION:ST LINEAR TRIAL LEAD, 50CM WITH PRE-LOADED 0.014 INCHES STYLET (STREAMLINED) THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR EVALUATION AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A TRIAL PATIENT WAS ADMITTED TO THE EMERGENCY ROOM FOR CHEST PAINS. THE PHYSICIAN EXPLANTED THE PATIENT'S LEADS AND THE PATIENT'S PAIN HAS SINCE SUBSIDED. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A TRIAL PATIENT WAS ADMITTED TO THE EMERGENCY ROOM FOR CHEST PAINS. THE PHYSICIAN EXPLANTED THE PATIENT¿S LEADS AND THE PATIENT'S PAIN HAS SINCE SUBSIDED. 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-2218-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R