BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2173441 · Received July 23, 2011

    Report

    Report Number
    3006630150-2011-01133
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICE FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A TRIAL PATIENT'S LEAD PULL, THE PATIENT COMPLAINED OF PAIN. A CT SCAN WAS TAKEN AND THE PHYSICIAN BELIEVED HE SAW TWO CONTACTS FROM THE LEAD LEFT IMPLANTED IN THE PATIENT. THE PATIENT UNDERWENT ANOTHER PROCEDURE TO REMOVE THE CONTACTS, BUT DURING THE PROCEDURE THE CONTACTS COULD NOT BE FOUND. AN X-RAY WAS TAKEN AND LAMANECTOMY PERFORMED AND BOTH CONFIRMED NO CONTACTS REMAINED IMPLANTED IN THE PATIENT. THE PHYSICIAN BELIEVED THAT WHAT WAS THOUGHT TO BE THE CONTACTS WAS ACTUALLY DYE FROM THE MYLEGRAM. 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-2218-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention