BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2101087 · Received May 24, 2011

    Report

    Report Number
    3006630150-2011-00744
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE THERAPY. THE BSC REPRESENTATIVE MET WITH THE PATIENT AND DISCOVERED HIGH IMPEDANCES ON 4 CONTACTS. THE PHYSICIAN INTERROGATED THE SYSTEM AND DISCOVERED THE INSULATION OF THE LEAD EXTENSION WAS DAMAGED. THE LEAD EXTENSION WAS EXPLANTED AND REPLACED WITH A NEW LEAD EXTENSION. 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-3138-55 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention