BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2143255 · Received June 28, 2011

    Report

    Report Number
    3006630150-2011-00975
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 5, 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
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. A REVIEW OF THE STERILIZATION RECORDS OF THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-2352-70 SERIAL# (B)(4) DESCRIPTION: LINEAR 3-4 LEAD 70CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR EVALUATION AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT UNDERWENT A LEAD EXPLANT DUE TO LEAD PROTRUSION. THE LEAD WAS PROTRUDING FROM THE BACK OF THE PATIENT'S HEAD; CAUSING DISCOMFORT. THE PHYSICIAN RE-IMPLANTED THE PATIENT WITH A NEW LEAD AND THE PATIENT WAS PUT ON ORAL ANTIBIOTIC AS A PRECAUTION OF INFECTION. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT UNDERWENT A LEAD EXPLANT DUE TO LEAD PROTRUSION. THE LEAD WAS PROTRUDING FROM THE BACK OF THE PATIENT'S HEAD; CAUSING DISCOMFORT. THE PHYSICIAN RE-IMPLANTED THE PATIENT WITH A NEW LEAD AND THE PATIENT WAS PUT ON ORAL ANTIBIOTIC AS A PRECAUTION OF INFECTION. 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-2352-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention