BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2832018 · Received November 14, 2012

    Report

    Report Number
    1644487-2012-02750
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    January 29, 2010
    Report Date
    October 22, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY MANUFACTURER, LEAD PIN APPEARED TO BE NOT FULLY PAST THE CONNECTER BLOCK OF THE GENERATOR.

    Description of Event or Problem · 1

    UPON REVIEW OF X-RAYS PERFORMED FOR MEDWATCH REPORT NUMBER 1644487-2012-02403, IT WAS FOUND THAT THE LEAD PIN WAS NOT FULLY INSERTED AND THAT THERE WAS A SHARP ANGLE IN THE LEAD. THE PRESENT FILE WILL HOUSE THE "PIN NOT FULLY INSERTED" EVENT AND THE MEDWATCH REPORT NUMBER 1644487-2012-02403 WILL FOLLOW UP ON THE LEAD ISSUE. THE PATIENT HAD THEIR GENERATOR REPLACED ON (B)(6) 2012 BUT AT THIS TIME IF HAS NOT BEEN RETURNED FOR ANALYSIS. X-RAY REVIEW SHOWED THE GENERATOR APPEARED IN THE UPPER LEFT CHEST IN A NORMAL PLACEMENT. THE FILTER FEED-THROUGH WIRES APPEARED TO BE INTACT. THE LEAD CONNECTOR PIN WAS NOT FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. NO STRAIN-RELIEF BEND OR LOOP WAS USED. NO TIE-DOWN WAS SUED EITHER. A STRAIN RELIEF BEND SHOULD BE PLACED STARTING 3CM FROM THE ANCHOR TETHER AND SHOULD BE SECURED WITH A TIE-DOWN PARALLEL TO THE ANCHOR TETHER. A LARGE LOOP SHOULD THEN BE FORMED AND SECURED WITH AN ADDITIONAL TIE-DOWN TO ALLOW FOR FULL NECK MOVEMENT IN ALL DIRECTIONS. PART OF THE LEAD WAS BEHIND THE GENERATOR. ONE ACUTE ANGLE WAS OBSERVED AT THE LEAD BIFURCATION. NO LEAD BREAK WAS VISIBLE. BASED ON THE X-RAYS IMAGES, THE CAUSE FOR THE HIGH IMPEDANCE IS THE LEAD PIN NOT FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. NO FURTHER INFORMATION HAS BEEN ATTAINED AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT STILL HAS HIGH IMPEDANCE IN SPITE OF THEIR GENERATOR REPLACEMENT. THE PHYSICIANS ARE ATTEMPTING TO HAVE THE LEAD REPLACED BUT THEY ARE WAITING FOR THE PARENTAL DECISION ABOUT AN EVENTUAL LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200742

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR