BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION® MONTAGE

    MDR report key: 5954969 · Received September 15, 2016

    Report

    Report Number
    3006630150-2016-02417
    Event Type
    Malfunction
    Date Received
    September 15, 2016
    Date of Event
    August 24, 2016
    Report Date
    August 24, 2016
    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

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-2408-56 SERIAL #: (B)(4) DESCRIPTION: AVISTA MRI PERC LEAD KIT,56CM.

    Additional Manufacturer Narrative · 1

    SC-2408-56 (B)(4): DEVICE EVALUATION INDICATED THAT THE COMPLAINT HAD BEEN CONFIRMED. VISUAL INSPECTION REVEALED THAT THE LEAD BODY 14 CM FROM THE DISTAL END HAD BEEN FLATTENED. IT APPEARED THAT EXCESSIVE FORCE WAS APPLIED ON THE LEAD AND IT RESULTED IN DEFORMATION. X-RAY INSPECTION FOUND FRACTURED CABLES AROUND DAMAGED SECTION OF THE LEAD. THE FRACTURED CABLES RESULTED IN THE REPORTED LOSS OF STIMULATION. THERE WERE NO EXPOSED CABLES. REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES WHEN THE LEAD WAS MANUFACTURED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A WRONG TRACKING NUMBER WAS GIVEN AND THE BOSTON SCIENTIFIC REPRESENTATIVE DID NOT HAVE THE TRACKING NUMBER ANYMORE. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN. 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 THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCES. IT WAS ALSO NOTED THAT THERE WAS LEAD MIGRATION CONFIRMED THROUGH FLUOROSCOPY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. MALFUNCTION OF THE LEAD WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCES. IT WAS ALSO NOTED THAT THERE WAS LEAD MIGRATION CONFIRMED THROUGH FLUOROSCOPY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. MALFUNCTION OF THE LEAD WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCES. IT WAS ALSO NOTED THAT THERE WAS LEAD MIGRATION CONFIRMED THROUGH FLUOROSCOPY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. MALFUNCTION OF THE LEAD WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605375 PRECISION® MONTAGE SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR