BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3910595 · Received July 2, 2014

    Report

    Report Number
    1644487-2014-01673
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, LEAD PIN NOT FULLY INSERTED PAST THE CONNECTOR BLOCK OF GENERATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE DIAGNOSTICS RESULTED IN HIGH IMPEDANCE (5348 OHMS). THE GENERATOR WAS PROGRAMMED OFF AND X-RAYS WERE TAKEN. IT WAS REPORTED THAT THE PATIENT HAS BEEN DIGGING AT THE INCISION SITE SINCE IMPLANT. IT WAS REPORTED THAT THE PATIENT WAS RECENTLY IMPLANTED. THE PATIENT WAS SEEN BY THE PHYSICIAN AGAIN AND DEVICE DIAGNOSTICS WERE PERFORMED WHICH RESULTED IN IMPEDANCE VALUES FROM 5200 OHMS TO HIGH IN THE 5000 RANGE. THE PHYSICIAN INDICATED THAT THE X-RAYS WERE OK. X-RAYS WERE SENT TO MANUFACTURER FOR REVIEW. BASED ON THE X-RAYS RECEIVED, IT APPEARS THAT THE LEAD PIN NOT BEING FULLY INSERTED MAY BE THE CAUSE OF THE DEVICE¿S HIGH IMPEDANCE. THERE WAS NOTHING SEEN THAT WOULD INDICATE THERE WAS ANY DAMAGE TO THE GENERATOR OR LEAD; HOWEVER, THE PRESENCE OF A MICRO-FRACTURE IN THE LEAD CANNOT BE RULED OUT. AS THE ENTIRE LEAD COULD NOT BE ASSESSED, CONTINUITY IN THAT PORTION OF THE LEAD CANNOT BE CONFIRMED. SURGERY IS LIKELY, BUT HAS NOT BEEN PERFORMED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AT WHICH TIME THE LEAD PIN WAS REINSERTED INTO THE GENERATOR HEADER. IT WAS REPORTED THAT DEVICE DIAGNOSTICS AFTER THE LEAD PIN WAS REINSERTED WAS WITHIN NORMAL LIMITS (2888 OHMS AND 2740 OHMS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387665 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 3817

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR