BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2110272 · Received June 1, 2011

    Report

    Report Number
    3006630150-2011-00807
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT THE POCKET REVISION. DURING THE REVISION THE PHYSICIAN TIGHTENED UP THE PATIENT'S POCKET SITE TO REDUCE MOVEMENT OF THE IPG.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD FALLEN AND THE STIMULATION HAS CHANGED. THE PATIENT'S DATABASE WAS ANALYZED AND NO ANOMALIES WERE NOTED. AN X RAY TAKEN REVEALED NOTHING. THE PATIENT HAS LOST WEIGHT, NOT DEVICE RELATED, AND WILL UNDERGO A POCKET REVISION DUE TO DISCOMFORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD FALLEN AND THE STIMULATION HAS CHANGED. THE PATIENT'S DATABASE WAS ANALYZED AND NO ANOMALIES WERE NOTED. AN X RAY TAKEN REVEALED NOTHING. THE PATIENT HAS LOST WEIGHT, NOT DEVICE RELATED, AND WILL UNDERGO A POCKET REVISION DUE TO DISCOMFORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention