BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2223477 · Received August 25, 2011

    Report

    Report Number
    3006630150-2011-01327
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD EXTENSIONS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-3138-25, SERIAL # (B)(4), DESCRIPTION: PHASE III LEAD EXTENSION - 25 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN WHERE THE HEADERS ON EXTENSIONS WERE. THE PHYSICIAN EXPLANTED THE PATIENT'S TWO EXTENSION. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN WHERE THE HEADERS ON EXTENSIONS WERE. THE PHYSICIAN EXPLANTED THE PATIENT'S TWO EXTENSION. THE PATIENT IS 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-3138-25 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention