BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2770887 · Received October 3, 2012

    Report

    Report Number
    3006630150-2012-01829
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 30, 2012
    Report Date
    August 30, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-1110-02, SERIAL#: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT DURING VISUAL INSPECTION OF THE LEADS REVEALED THAT IT WAS CLEANLY CUT APPROXIMATELY 19 INCHES FROM THE DISTAL END. THE DAMAGE TO THE LEAD IS CONSISTENT WITH DAMAGES DONE DURING THE EXPLANT PROCEDURE AND ARE NOT CONSIDERED A FAILURE. DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, PERFORMANCE AND ELECTRICAL IMAGING TESTS PERFORMED. THE IPG WAS ANALYZED AND PASSED ALL TESTS. THEREFORE, THE IPG EXHIBITS NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO EXPERIENCING DISCOMFORT AT THE LEAD SITE. THE PAIN THAT THE PATIENT WAS IMPLANTED FOR HAS RESOLVED ITSELF AND THE DEVICE WAS EXPLANTED. THE PATIENT IS REPORTEDLY DOING FINE FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO EXPERIENCING DISCOMFORT AT THE LEAD SITE. THE PAIN THAT THE PATIENT WAS IMPLANTED FOR HAS RESOLVED ITSELF AND THE DEVICE WAS EXPLANTED. THE PATIENT IS REPORTEDLY DOING FINE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention