BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3081777 · Received April 29, 2013

    Report

    Report Number
    3006630150-2013-00832
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED. VISUAL INSPECTION OF THE LEAD FOUND THAT THE LEAD BODY HAS A NOTICEABLE MARK DONE BY THE STYLET PUNCTURING THE LEAD BETWEEN CONTACTS # 7 AND #8 ON THE DISTAL ARRAY. REVIEW OF THE DEVICE HISTORY RECORD DIDN¿T REVEAL ANY ANOMALY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A TRIAL PROCEDURE, THE LEAD WAS FRACTURED. THE PHYSICIAN KEPT PUSHING THE STYLET AND IT POKED THROUGH CAUSING DISCOMFORT TO THE PATIENT. THE LEAD CURVED IN AN ANGLE AND THE STYLET CAME OUT OF THE TIP OF THE LID. THE PHYSICIAN ABORTED THE TRIAL AND PULLED THE LEAD OUT WHICH RESOLVED PATIENT'S DISCOMFORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A TRIAL PROCEDURE, THE LEAD WAS FRACTURED. THE PHYSICIAN KEPT PUSHING THE STYLET AND IT POKED THROUGH CAUSING DISCOMFORT TO THE PATIENT. THE LEAD CURVED IN AN ANGLE AND THE STYLET CAME OUT OF THE TIP OF THE LID. THE PHYSICIAN ABORTED THE TRIAL AND PULLED THE LEAD OUT WHICH RESOLVED PATIENT'S DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184598 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention