BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1921062 · Received December 9, 2010

    Report

    Report Number
    3006630150-2010-02049
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPG PASSED VISUAL, PHOTOGRAPHIC IMAGING AND PERFORMANCE TESTS DONE. THE COMPLAINT HAS BEEN CONFIRMED. THE DEFECT IN SEEPROM 1 ( HARDWARE) RESULTS IN THE GENERATION OF ERROR CODE. THE ROOT CAUSE OF THE HARDWARE ANOMALY IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT RECEIVED AN ERROR CODE ON THEIR REMOTE CONTROL. A BSN REPRESENTATIVE ATTEMPTED TO CLEAR THE ERROR CODE BUT WAS UNSUCCESSFUL. AN IPG REPLACEMENT SURGERY HAS BEEN RECOMMENDED AS THE PATIENT'S IPG IS NOT FUNCTIONING PER SPECIFICATIONS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT RECEIVED AN ERROR CODE ON THEIR REMOTE CONTROL. A BSN REP ATTEMPTED TO CLEAR THE ERROR CODE BUT WAS UNSUCCESSFUL. AN IPG REPLACEMENT SURGERY HAS BEEN RECOMMENDED AS THE PT'S IPG IS NOT FUNCTIONING PER SPECIFICATIONS.

    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 UNK Required Intervention