BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1884973 · Received October 22, 2010

    Report

    Report Number
    3006630150-2010-01748
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 2, 2010
    Manufacturer
    BOSTON SCIENTIFC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PADDLE LEAD WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A REVISION DUE TO INEFFECTIVE THERAPY WHEN THE PHYSICIAN WENT TO REPLACE THE PADDLE LEAD 5 CONTACTS FELL OFF THE LEAD. THE CONTACTS WERE REMOVED FROM THE PT AND THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention