BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1953725 · Received January 4, 2011

    Report

    Report Number
    3006630150-2010-02204
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 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
    TX, 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'S SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE INCISION SITE. THE PT'S SYMPTOMS WERE FEVER AND INFLAMMATION AT THE INCISION SITE. THE PHYSICIAN DOESN'T THINK THE INFECTION IS RELATED TO THE DEVICE.

    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 59 YR Required Intervention ARTISAN 2X8 LIM, 70CM: MODEL#: SC-8216-70| SERIAL#: (B)(4)