BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2820836 · Received November 6, 2012

    Report

    Report Number
    3006630150-2012-02005
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING POCKET DISCOMFORT AND FELT THE IPG HEATED UP, ESPECIALLY DURING CHARGING. THE PHYSICIAN ASSESSED THAT THE IPG WAS TOO SHALLOW. THE PATIENT UNDERWENT A POCKET REVISION AND THE IPG WAS REPOSITIONED DEEPER IN THE POCKET. THE PATIENT WAS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING POCKET DISCOMFORT AND FELT THE IPG HEATED UP, ESPECIALLY DURING CHARGING. THE PHYSICIAN ASSESSED THAT THE IPG WAS TOO SHALLOW. THE PATIENT UNDERWENT A POCKET REVISION AND THE IPG WAS REPOSITIONED DEEPER IN THE POCKET. THE PATIENT WAS REPORTEDLY DOING WELL.

    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 Required Intervention