BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2110288 · Received June 1, 2011

    Report

    Report Number
    3006630150-2011-00799
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION FOR INADEQUATE THERAPY, THE PHYSICIAN REPLACED THE PADDLE LEAD DUE TO HIGH IMPEDANCES. THE PATIENT WAS IMPLANTED WITH A NEW PADDLE LEAD AND REPORTEDLY DOING FINE AFTER THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION FOR INADEQUATE THERAPY, THE PHYSICIAN REPLACED THE PADDLE LEAD DUE TO HIGH IMPEDANCES. THE PATIENT WAS IMPLANTED WITH A NEW PADDLE LEAD AND REPORTEDLY DOING FINE AFTER THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention