BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2151752 · Received July 6, 2011

    Report

    Report Number
    3006630150-2011-01004
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2158-50, (B)(4), DESCRIPTION: LINEAR LEAD, 50 CM WITH PRE-LOADED 0.014 INCH STYLET THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN 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 THE PATIENT WAS EXPLANTED DUE TO AN INFECTION AT THE IPG SITE. THE PATIENT'S SYMPTOMS INCLUDED PUS, REDNESS, AND SWELLING AROUND THE IPG SITE. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE POCKET WAS FLUSHED OUT AND THE PATIENT WAS GIVEN ORAL ANTIBIOTICS. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO AN INFECTION AT THE IPG SITE. THE PATIENT'S SYMPTOMS INCLUDED PUS, REDNESS, AND SWELLING AROUND THE IPG SITE. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE POCKET WAS FLUSHED OUT AND THE PATIENT WAS GIVEN ORAL ANTIBIOTICS. THE PATIENT WAS 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention