BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2122412 · Received June 13, 2011

    Report

    Report Number
    3006630150-2011-00900
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#SC-1110-02 SERIAL# (B)(4) DESCRIPTION: IPG KIT (WITHOUT PULL-THROUGH TUNNELER). 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 PATIENT WAS EXPERIENCING SEVERE PAIN AT THE LEAD SITE. THE PATIENT REPORTED FEELING A PULL AND A STRONG SPAZ FOLLOWED BY FALLING ONTO THE FLOOR WHEN GETTING OUT OF BED. UPON ASSESSMENT, THE PHYSICIAN CHOSE TO EXPLANT THE PATIENT¿S PRECISION SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT CONTACTS WERE PULLED OFF THE LEAD. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING SEVERE PAIN AT THE LEAD SITE. THE PATIENT REPORTED FEELING A PULL AND A STRONG SPAZ FOLLOWED BY FALLING ONTO THE FLOOR WHEN GETTING OUT OF BED. UPON ASSESSMENT, THE PHYSICIAN CHOSE TO EXPLANT THE PATIENT'S PRECISION SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT CONTACTS WERE PULLED OFF THE LEAD. 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-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention