BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1936050 · Received December 10, 2010

    Report

    Report Number
    3006630150-2010-02096
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE DOCTOR DETERMINED THAT IT WAS AN ALLERGIC REACTION BUT DOES NOT KNOWN WHAT IT IS FROM. THE PT UNDERWENT A POCKET REVISION PROCEDURE, AND THE POCKET SITE WAS RELOCATED. THE PT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    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 57 YR Required Intervention