BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2061573 · Received April 18, 2011

    Report

    Report Number
    3006630150-2011-00522
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE REVISION PROCEDURE. THE PHYSICIAN MOVED THE IPG FROM THE LEFT BUTTOCK TO THE RIGHT ABDOMEN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO A POCKET REVISION DUE TO DISCOMFORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO A POCKET REVISION DUE TO DISCOMFORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention