BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3900480 · Received June 27, 2014

    Report

    Report Number
    1644487-2014-01611
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    April 7, 2014
    Report Date
    June 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    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 THE VNS PATIENT¿S DEVICE SHOWED HIGH IMPEDANCE. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATED THAT THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT. THE LEAD IMPEDANCE WITH THE NEW VNS SYSTEM WAS WITHIN NORMAL LIMITS. IT WAS REPORTED THAT THE LEAD IMPEDANCE PRIOR TO DEVICE REPLACEMENT WAS HIGH (DC DC CODE - 7). THE DEVICE WAS OFF (0MA) AT INTERROGATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED CONTAINING SOME PROGRAMMING HISTORY FOR THE PATIENT, ON WHICH THE HIGH IMPEDANCE WAS CONFIRMED FROM THE (B)(6) 2014 CLINIC DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377051 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 010464

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR