BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3973087 · Received August 1, 2014

    Report

    Report Number
    3006630150-2014-01733
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED THAT THE CONTACTS WERE LOOSENED DURING THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A REVISION PROCEDURE, IN THE COURSE OF REINSERTING THE LEAD IT WAS VISIBLE ON X-RAY THAT THREE OF THE CONTACTS WERE LOOSENED FROM THE LEAD. THE CONTACTS DID NOT COME OFF FROM THE LEAD. IT WAS DETERMINED INTRAOPERATIVELY TO REPLACE THE LEAD. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A REVISION PROCEDURE, IN THE COURSE OF REINSERTING THE LEAD IT WAS VISIBLE ON X-RAY THAT THREE OF THE CONTACTS WERE LOOSENED FROM THE LEAD. THE CONTACTS DID NOT COME OFF FROM THE LEAD. IT WAS DETERMINED INTRAOPERATIVELY TO REPLACE THE LEAD. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450005 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR