BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1655336 · Received April 2, 2010

    Report

    Report Number
    1644487-2010-00807
    Event Type
    Malfunction
    Date Received
    April 2, 2010
    Date of Event
    January 1, 2010
    Report Date
    March 4, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT HAD THE VNS LEAD AND GENERATOR EXPLANTED DUE TO "MALFUNCTION". THE MALFUNCTION WAS NOT SPECIFIED. THE EXPLANTED LEAD AND GENERATOR HAVE BEEN RETURNED. ANALYSIS OF THE LEAD PORTION RETURNED DID NOT IDENTIFY ANY ANOMALIES. THE RESISTANCE MEASUREMENT TAKEN DURING DECONTAMINATION VERIFIED AN ELECTRICAL AND MECHANICAL CONTACT BETWEEN THE GENERATOR AND CONNECTOR PIN AT ONE POINT IN TIME. THE ELECTRODE ARRAY WAS NOT RETURNED. ANALYSIS OF THE GENERATOR IS STILL PENDING. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYZ CYBERONICS, INC. 102 7416

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR