BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3183031 · Received June 21, 2013

    Report

    Report Number
    3006630150-2013-01298
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE LEAD PASSED MECHANICAL TESTS PERFORMED. THE COMPLAINT HAS BEEN CONFIRMED. VISUAL INSPECTION FOUND THAT THE LEAD PROXIMAL ARRAY IS FRACTURED BETWEEN CONTACTS # 5 AND 6. HIGH IMPEDANCE READINGS WERE REGISTERED AT CONTACTS # 2, 3, 4, 5, AND 6. X-RAY INSPECTION CONFIRMED BROKEN CABLES ALONG THE PROXIMAL ARRAY OF THE LEAD. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT LOST STIMULATION. AN X-RAY CONFIRMED THAT THE LEAD WAS BENT. A SYSTEM CHECK REVEALED THAT THE LEAD DISPLAYED HIGH IMPEDANCES. THE PHYSICIAN SUSPECTED THAT THE ISSUE WAS CAUSED BY EITHER THE LEAD OR THE PATIENT¿S ANATOMY. THE PHYSICIAN EXPLANTED THE PRECISION SYSTEM AND IMPLANTED A COMPETITOR¿S SYSTEM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT LOST STIMULATION. AN X-RAY CONFIRMED THAT THE LEAD WAS BENT. A SYSTEM CHECK REVEALED THAT THE LEAD DISPLAYED HIGH IMPEDANCES. THE PHYSICIAN SUSPECTED THAT THE ISSUE WAS CAUSED BY EITHER THE LEAD OR THE PATIENT¿S ANATOMY. THE PHYSICIAN EXPLANTED THE PRECISION® SYSTEM AND IMPLANTED A COMPETITOR¿S SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283676 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1