BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2173395 · Received July 23, 2011

    Report

    Report Number
    3006630150-2011-01055
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-8216-70 SERIAL#: (B)(4) MODEL DESCRIPTION: ARTISAN 2X8 PADDLE LEAD (LIM), 70 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN BECAUSE THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION RECORDS OF THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION AT THE POCKET SITE AND AN OPEN SORE. THE PATIENT HAD BEEN EXPERIENCING REDNESS AND OOZING. THE PHHYSICAN PRESCRIBED KEFLEX TO THE PATIENT AND THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION AT THE POCKET SITE AND AN OPEN SORE. THE PATIENT HAD BEEN EXPERIENCING REDNESS AND OOZING. THE PHHYSICAN PRESCRIBED KEFLEX TO THE PATIENT AND THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE EXPLANT PROCEDURE.

    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