BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 4542716 · Received February 24, 2015

    Report

    Report Number
    3006630150-2015-00394
    Event Type
    Malfunction
    Date Received
    February 24, 2015
    Report Date
    January 30, 2015
    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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-30, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 30CM. THE EXPLANTED LEADS WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS 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¿S RANGE OF SHARP PAIN HAD SPREAD OUT, AND THE PATIENT¿S LEAD DISPLAYED HIGH IMPEDANCE READINGS. THE PHYSICIAN SUSPECTED THAT ONE OF THE LEADS WAS FRACTURED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS WERE REPLACED. THE PHYSICIAN NOTED THAT NO WIRES WERE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130027 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-30 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1