BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3781194 · Received April 30, 2014

    Report

    Report Number
    3006630150-2014-00920
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 16, 2014
    Report Date
    April 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE EXPLANT PROCEDURE, WHEN THE PHYSICIAN REMOVED THE LEAD, THE LEAD WAS FRACTURED, THE LEAD CONTACT PORTION BROKE OFF AND THE WIRE FILAMENTS WAS PULLED OUT. THE PHYSICIAN WAS NOT ABLE TO RETRIEVE THE FRACTURED CONTACT TIP OF THE LEAD AND WAS LEFT INSIDE THE PATIENT¿S EPIDURAL SPACE. THE PATIENT WAS ADVISED NOT TO UNDERGO AN MRI. NO FURTHER COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260772 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention