BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3932997 · Received July 14, 2014

    Report

    Report Number
    3006630150-2014-01617
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2158-50, SERIAL/LOT # (B)(4), DESCRIPTION: LINEAR LEAD WITH ENHANCED STYLET, 50CM.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT HAS BEEN CONFIRMED REGARDING LEAD S/N (B)(4). VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE BENT/KINKED LOCATION IS 1 CM FROM THE SET SCREW MARK OF THE CLIK ANCHOR. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT OF HIGH IMPEDANCE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE SC-2218-50, S/N (B)(4), 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¿S LEAD DISPLAYED HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION AND THE PHYSICIAN REPLACED THE LEAD. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD DISPLAYED HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION AND THE PHYSICIAN REPLACED THE LEAD. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410790 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2158-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention