BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1834549 · Received September 9, 2010

    Report

    Report Number
    3006630150-2010-01567
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    Z-0960-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CORRECTION/REMOVAL REPORTING NUMBER FOR FIELD (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE BSN FIELD CLINICAL ENGINEER (FCE) ATTEMPTED TO REPROGRAM THE PT BUT WAS UNSUCCESSFUL DUE TO THE 10H0 ERROR CODE. THE BSN FCE SUGGESTED FOR THE PT TO HAVE AN IPG REVISION, HOWEVER THE PT DOES NOT WANT TO UNDERGO THE REVISION.

    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 77 YR