BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3163668 · Received June 11, 2013

    Report

    Report Number
    3006630150-2013-01197
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-4316, SERIAL/LOT #: (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Additional Manufacturer Narrative · 1

    (B)(4) (LOT # 15546224) DEVICE EVALUATION INDICATED THAT VISUAL INSPECTION REVEALED THAT ONE OF THE CLIK ANCHORS HAS TORN EYELET. (B)(4) (LOT # 14802057) IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING PAIN AND DISCOMFORT DUE TO THE CLIK ANCHORS. THE PATIENT UNDERWENT A REMOVAL OF THE CLIK ANCHORS AND WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING PAIN AND DISCOMFORT DUE TO THE CLIK ANCHORS. THE PATIENT UNDERWENT A REMOVAL OF THE CLIK ANCHORS AND WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263586 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4316 15546224

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention