BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2202739 · Received August 11, 2011

    Report

    Report Number
    3006630150-2011-01276
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 25, 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
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-2218-70, (B)(4) & (B)(4), DESCRIPTION: LINEAR ST LEAD WITH PRELOADED ENHANCED STYLET - 70 CM. 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 FOR THE IPG AND LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG AND LEADS 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 MIDLINE INCISION. THE PATIENT'S SYMPTOMS INCLUDED MINOR OOZING, IRRITATION AND SORENESS AT THE POCKET SITE. THE PHYSICIAN BELIEVES THE INFECTION WAS DUE TO THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE MIDLINE INCISION. THE PATIENT'S SYMPTOMS INCLUDED MINOR OOZING, IRRITATION AND SORENESS AT THE POCKET SITE. THE PHYSICIAN BELIEVES THE INFECTION WAS DUE TO 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 41 YR Required Intervention