BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4201170 · Received October 27, 2014

    Report

    Report Number
    3006630150-2014-02473
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN EXISTING LEAD IMPLANTED THAT WAS NOT UTILIZED. THE TAIL OF THE LEAD WAS ERODING THROUGH THE SKIN AND WAS CAUSING DISCOMFORT BUT NO SKIN BREAKAGE NOTED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE PHYSICIAN EXPOSED THE TAILS AND CUT THE ENDS OFF. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681630 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention