BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2060193 · Received April 15, 2011

    Report

    Report Number
    3006630150-2011-00538
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-1110 (B)(4) DESCRIPTION: IMPLANTABLE PULSE GENERATOR (IPG) A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE PADDLE LEAD AND IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE PADDLE LEAD AND IPG FOUND THEM TO BE SATISFACTORY. 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 PATIENT'S LEAD HAD ERODED THROUGH THE PATIENT'S SKIN ABOUT AN 1/8 OF AN INCH. THE PATIENT ELECTED TO HAVE THE SYSTEM EXPLANTED INSTEAD OF UNDERGOING A LEAD REVISION. 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-8120-70 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention