BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 4002186 · Received August 12, 2014

    Report

    Report Number
    1644487-2014-01995
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO BATTERY DEPLETION, THE VNS PATIENT¿S REPLACEMENT GENERATOR WAS TESTED WITH THE EXISTING LEAD OUTSIDE THE GENERATOR POCKET AND DIAGNOSTIC RESULTS SHOWED LEAD IMPEDANCE WITHIN NORMAL LIMITS. THE GENERATOR WAS PLACED IN THE GENERATOR POCKET AND SUBSEQUENT DIAGNOSTIC RESULTS REVEALED HIGH IMPEDANCE. THE LEAD PINS WERE RE-INSERTED INTO THE GENERATOR HEADER BUT THE DEVICE CONTINUED TO SHOW HIGH IMPEDANCE. THE PATIENT¿S PREVIOUS GENERATOR WAS TESTED WITH THE LEAD AND LEAD IMPEDANCE WAS AT FIRST WITHIN NORMAL LIMITS; HOWEVER, SUBSEQUENT DIAGNOSTIC RESULTS ALSO SHOWED HIGH IMPEDANCE. THE GENERATOR WAS TESTED WITH THE TEST RESISTOR AND DIAGNOSTIC RESULTS SHOWED LEAD IMPEDANCE WITHIN NORMAL LIMITS. THE PATIENT¿S GENERATOR AND LEAD WERE REPLACED DURING THE PROCEDURE. THE EXPLANTED GENERATOR AND LEAD HAVE NOT BEEN RETURNED TO DATE.

    Description of Event or Problem · 1

    THE REPLACEMENT GENERATORS WERE RETURNED FOR ANALYSIS. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS OF THE TWO GENERATORS THAT WERE OPENED, BUT NOT USED WAS COMPLETED ON 09/24/2014 AND 09/25/2014. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATORS. THE EXPLANTED LEAD AND GENERATOR HAVE NOT BEEN RECEIVED FOR ANALYSIS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480153 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 38008C

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR