BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2882708 · Received December 20, 2012

    Report

    Report Number
    3006630150-2012-02427
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT'S POCKET SITE WAS REVISED DUE TO DISCOMFORT. THE PHYSICIAN EXAMINED THE PATIENT AND DETERMINED THAT THE IPG WAS TOO SUPERFICIAL IN THE POCKET SITE WHICH CAUSED THE DISCOMFORT. THE POCKET SITE WAS RELOCATED AND THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT'S POCKET SITE WAS REVISED DUE TO DISCOMFORT. THE PHYSICIAN EXAMINED THE PATIENT AND DETERMINED THAT THE IPG WAS TOO SUPERFICIAL IN THE POCKET SITE WHICH CAUSED THE DISCOMFORT. THE POCKET SITE WAS RELOCATED AND THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE REVISION.

    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 Hospitalization| R