BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1892651 · Received November 3, 2010

    Report

    Report Number
    3006630150-2010-01861
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS INFECTED AT THE BATTERY SITE. THE PT WAS EXPERIENCING DRAINAGE AND PUS AT THE POCKET SITE. THE PHYSICIAN ALSO NOTED THAT THERE WAS A HOLE IN THE POCKET SITE WHERE THE DEVICE WAS VISIBLE. THE PHYSICIAN EXPLANTED THE PT AND PRESCRIBED ORAL ANTIBIOTICS.

    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 64 YR Required Intervention MODEL #: SC-8216-50| ARTISAN 2X8 PADDLE LEAD (LIM), 50 CM| SERIAL #: (B)(4)