BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2191973 · Received August 4, 2011

    Report

    Report Number
    3006630150-2011-01203
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S INFECTION HAD RETURNED AND THAT THE PATIENT WILL BE EXPLANTED. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION IS DEVICE OR PROCEDURE BUT DUE TO THE PATIENT PICKING AT THE WOUND AND BEING UNHYGENIC IN GENERAL. THE PATIENT'S SYMPTOMS INCLUDED DRAINAGE AND FEVER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2218-50, SERIAL # (B)(4), DESCRIPTION: ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCH STYLET THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR EVALUATION AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. 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 THE PATIENT WAS EXPERIENCING PUS LEAKAGE FROM HER POCKET SITE. THE PATIENT MET WITH HER FAMILY PHYSICIAN WHO CONFIRMED THE PATIENT HAD AN INFECTION. THE PATIENT WAS GIVEN ANTIBIOTICS AND WILL FOLLOW UP WITH HER PHYSICIAN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PUS LEAKAGE FROM HER POCKET SITE. THE PATIENT MET WITH HER FAMILY PHYSICIAN WHO CONFIRMED THE PATIENT HAD AN INFECTION. THE PATIENT WAS GIVEN ANTIBIOTICS AND WILL FOLLOW UP WITH HER PHYSICIAN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PUS LEAKAGE FROM HER POCKET SITE. THE PATIENT MET WITH HER FAMILY PHYSICIAN WHO CONFIRMED THE PATIENT HAD AN INFECTION. THE PATIENT WAS GIVEN ANTIBIOTICS AND WILL FOLLOW UP WITH HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention