BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2230011 · Received August 31, 2011

    Report

    Report Number
    3006630150-2011-01335
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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 DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-4316, LOT # 14302399, DESCRIPTION: CLIK ANCHOR (SET OF 2). DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, AND PERFORMANCE PERFORMED. NO DISCREPANCIES WERE IDENTIFIED. THE PATIENT WAS EXPLANTED DUE TO A PAIN FROM THE INITIAL PROCEDURE, AND THERE WAS NO OTHER COMPLAINT REPORTED ABOUT THE FUNCTIONALITY OF THE DEVICE. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG FOUND THEM TO BE SATISFACTORY. VISUAL INSPECTION OF BOTH LEADS REVEALED THAT THEY WERE PULLED AND CUT. DAMAGE TO THE DEVICES WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND ARE NOT CONSIDERED A FAILURE. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE LEADS FOUND THEM TO BE SATISFACTORY. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE CLIK ANCHORS FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO DISCOMFORT FOLLOWING THE PERMANENT IMPLANT. THE SYSTEM WAS WORKING PROPERLY PRIOR TO BEING EXPLANTED. 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 DISCOMFORT FOLLOWING THE PERMANENT IMPLANT. THE SYSTEM WAS WORKING PROPERLY PRIOR TO BEING EXPLANTED. 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 47 YR Required Intervention