BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1884522 · Received October 19, 2010

    Report

    Report Number
    3006630150-2010-01797
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 2, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A PADDLE LEAD REVISION DUE TO IT BEING FRACTURED. THE OLD PADDLE LEAD WAS EXPLANTED AND DISCARDED. THE PATIENT IS DOING WELL FOLLOWING THE REVISION. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE PADDLE LEAD REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DOESN'T FEEL ANY STIMULATION. THE PHYSICIAN WILL OPEN UP THE PATIENT'S POCKET SITE TO EXAMINE THE PADDLE LEAD FOR BREAKAGE. IF THE LEAD IS NOT PROPERLY WORKING IT WILL BE REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DOESN'T FEEL ANY STIMULATION. THE PHYSICIAN WILL OPEN UP THE PATIENT'S POCKET SITE TO EXAMINE THE PADDLE LEAD FOR BREAKAGE. IF THE LEAD IS NOT PROPERLY WORKING, IT WILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention IPG KIT WITHOUT PULL-THROUGH TUNNELER:| MODEL #SC-1110-02, (B)(4)