BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3532262 · Received December 23, 2013

    Report

    Report Number
    3006630150-2013-02710
    Event Type
    Malfunction
    Date Received
    December 23, 2013
    Date of Event
    November 4, 2013
    Report Date
    November 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD 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-2218-30, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 30CM. 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 WHEREIN ONE LEAD WAS REPLACED AS IT WAS VISIBLY BROKEN WHEN THE SPLITTERS WERE REMOVED. THE PATIENT WAS DOING WELL FOLLOWING PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION WHEREIN ONE LEAD WAS REPLACED AS IT WAS VISIBLY BROKEN WHEN THE SPLITTERS WERE REMOVED. THE PATIENT WAS DOING WELL FOLLOWING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671318 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR