BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3043523 · Received April 9, 2013

    Report

    Report Number
    3006630150-2013-00656
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    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-2158-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR LEAD WITH ENHANCED STYLET, 50CM.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION REVEALED LEAD WAS CLEANLY CUT APPROXIMATELY 8 CM FROM THE PROXIMAL END. THE DISTAL END PORTION OF THE LEAD WAS NOT RETURNED. THE DAMAGE TO THE LEAD IS CONSISTENT WITH DAMAGES DONE DURING THE EXPLANT PROCEDURE AND ARE NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LEAD SITE DISCOMFORT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE WHOLE SYSTEM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LEAD SITE DISCOMFORT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE WHOLE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146839 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2158-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention