BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2843036 · Received November 21, 2012

    Report

    Report Number
    3006630150-2012-02157
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WILL NO LONGER UNDERGO AN IPG REPLACEMENT. THE PATIENT IS HAPPY WITH PLACEMENT OF IPG AND IS GETTING GOOD COVERAGE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A POCKET REVISION DUE TO IPG SITE BEING UNCOMFORTABLE. THE PHYSICIAN WILL REPLACE THE IPG.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A POCKET REVISION DUE TO IPG SITE BEING UNCOMFORTABLE. THE PHYSICIAN WILL REPLACE THE IPG.

    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 58 YR Required Intervention