BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2180502 · Received July 27, 2011

    Report

    Report Number
    3006630150-2011-01190
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED PRODUCT ANALYSIS INDICATED THAT THE COMPLAINT WAS NOT CONFIRMED. THE IPG WAS ABLE TO LINK TO ASSOCIATED REMOTE CONTROL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT DUE TO COMMUNICATION ISSUE. THE PATIENT IS DOING WELL FOLLOWING THE REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT DUE TO COMMUNICATION ISSUE. THE PATIENT IS 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 55 YR Required Intervention