BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1971509 · Received January 21, 2011

    Report

    Report Number
    3006630150-2011-00069
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 31, 2010
    Report Date
    December 31, 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 BECAUSE THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE TRIAL PT'S LEAD PULL, THE PHYSICIAN NOTICED A SUPERFICIAL INFECTION AT THE LEAD SITE. THE PT HAD REDNESS AND PUS AT THE LEAD SITE. THE PHYSICIAN PRESCRIBED AN ORAL ANTIBIOTIC AND THE PT WAS REPORTEDLY DOING FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention STYLET (STREAMLINED)| MODEL#: SC-2218-50E, SERIAL#: (B)(4)| ST LINEAR TRIAL LEAD, 50CM WITH PRE-LOADED 0.014"