BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2021829 · Received March 17, 2011

    Report

    Report Number
    3006630150-2011-00366
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 27, 2011
    Report Date
    February 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE EXPLANTED LEAD FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE TRIAL PATIENT WENT TO THE ER WHERE THEY DISCOVERED PURULENT DISCHARGE FROM THE LEAD SITE. THE LEAD SITE WAS CLEANED AND THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS. THE TRIAL LEAD WAS REMOVED AS SCHEDULED. THE PHYSICIAN DID NOT BELIEVE THE INFECTION WAS DEVICE RELATED. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R