BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1970311 · Received January 14, 2011

    Report

    Report Number
    3006630150-2011-00049
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PADDLE LEAD HAD LOST INTEGRITY; SEVERAL ELECTRODES WERE DISLODGED FROM THE PADDLE AND THREE DISCONNECTED ELECTRODES WERE NOT RETURNED. SINCE THE PATIENT WAS EXPLANTED DUE TO LEAD MIGRATION AND THERE WAS NO SPECIFIC COMPLAINT ABOUT THE FUNCTIONALITY OF THE DEVICE, THE DAMAGE TO THE DEVICE WAS CONSIDERED AS AN EXPLANT PROCEDURE DAMAGE AND WAS NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION DUE TO MIGRATION, IT WAS DISCOVERED THAT THE LEAD WAS FRACTURED. IT IS UNKNOWN IF THE LEAD WAS FRACTURED DURING THE REVISION OR PRIOR TO THE REVISION. THE LEAD WAS REPLACED AND THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION DUE TO MIGRATION, IT WAS DISCOVERED THAT THE LEAD WAS FRACTURED. IT IS UNKNOWN IF THE LEAD WAS FRACTURED DURING THE REVISION OR PRIOR TO THE REVISION. THE LEAD WAS REPLACED AND THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention