BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4251830 · Received November 14, 2014

    Report

    Report Number
    3006630150-2014-02627
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 20, 2014
    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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A BURNING SHARP PAIN AT THE LEFT LUMBAR SPINE AROUND THE SCS SITE. IT WAS STATED THAT THE SITE WAS PAINFUL TO TOUCH AND APPEARED SUPERFICIAL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS RELOCATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736268 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention