BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3031435 · Received April 2, 2013

    Report

    Report Number
    3006630150-2013-00601
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 7, 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 INFORMATION WAS RECEIVED THAT THE REASON FOR THE EXPLANT PROCEDURE WAS INADEQUATE STIMULATION AND THAT THE PAIN AND TENDERNESS WERE RESOLVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM. MODEL #: SC-4316, SERIAL/LOT #: (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING TENDERNESS OVER HER IPG AND INCISION SITES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING TENDERNESS OVER HER IPG AND INCISION SITES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134264 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention