BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2113182 · Received June 3, 2011

    Report

    Report Number
    3006630150-2011-00828
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2366-70 (B)(6) DESCRIPTION: LINEAR 3-6 LEAD 70CM

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE LEADS FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A WOUND CHECK THE PHYSICIAN DISCOVERED THAT THE PATIENT'S LEAD WAS PROTRUDING THROUGH HER SCALP. THE PATIENT HAD NO COMPLAINTS AND DID NOT WANT TO BE EXPLANTED AS SHE WAS RECEIVING ADEQUATE COVERAGE. THE PHYSICIAN DECIDED TO CUT THE PORTION OF THE LEAD THAT WAS PROTRUDING. THE SECOND LEAD WAS LEFT IMPLANTED. ONLY A COUPLE OF STITCHES WERE NEEDED, NO INCISIONS WERE MADE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A WOUND CHECK THE PHYSICIAN DISCOVERED THAT THE PATIENT'S LEAD WAS PROTRUDING THROUGH HER SCALP. THE PATIENT HAD NO COMPLAINTS AND DID NOT WANT TO BE EXPLANTED AS SHE WAS RECEIVING ADEQUATE COVERAGE. THE PHYSICIAN DECIDED TO CUT THE PORTION OF THE LEAD THAT WAS PROTRUDING. THE SECOND LEAD WAS LEFT IMPLANTED. ONLY A COUPLE OF STITCHES WERE NEEDED, NO INCISIONS WERE MADE. 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-2366-70 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention