BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4090751 · Received September 15, 2014

    Report

    Report Number
    3006630150-2014-02089
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. X-RAY REVEALED THAT THE IPG WAS AT AN ANGLED POSITION IN WHICH THE BOTTOM PORTION OF THE IPG PROJECTED INTO THE BODY WHILE THE UPPER ASPECT WAS POINTED TOWARDS THE SKIN. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN THE IPG WILL BE REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569504 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention