BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3061823 · Received April 16, 2013

    Report

    Report Number
    3006630150-2013-00735
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    February 24, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A LOSS OF STIMULATION. IMPEDANCE MEASUREMENTS WERE TAKEN WHICH SHOWED HIGH IMPEDANCES ON TWO CONTACTS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE LEAD AND IMPLANT A NEW ONE. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161898 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2158-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1