BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3071741 · Received April 22, 2013

    Report

    Report Number
    3006630150-2013-00769
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S POCKET SITE WAS TOO HIGH AND WAS UNCOMFORTABLE TO THE PATIENT. THE PATIENT UNDERWENT A POCKET REVISION WHEREIN THE POCKET WAS MOVED DOWN BELOW THE WAISTLINE. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171938 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention