BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2821575 · Received November 6, 2012

    Report

    Report Number
    3006630150-2012-02030
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S FALL WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A FALL AND LOST STIMULATION. THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE. THE POCKET WAS REVISED TO BE MORE COMFORTABLE FOR THE PATIENT. NOTHING WAS IMPLANTED OR EXPLANTED. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A FALL AND LOST STIMULATION. THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE. THE POCKET WAS REVISED TO BE MORE COMFORTABLE FOR THE PATIENT. NOTHING WAS IMPLANTED OR EXPLANTED. THE PATIENT 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention