BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 3032895 · Received April 3, 2013

    Report

    Report Number
    1644487-2013-00855
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    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 HIGH LEAD IMPEDANCE WAS NOTED ON A PROGRAMMING DIAGNOSTICS FOR THE VNS LEAD. X-RAYS WERE REVIEWED IN THE HOSPITAL BUT NO ANOMALIES WERE FOUND. THE X-RAY REVIEWS INDICATED THAT THE PATIENT ALSO HAD CERVICAL SPINE PAIN AND SHORTNESS OF BREATH, BUT IT DID NOT NOTE ANY RELATIONSHIP TO THE VNS. THE X-RAYS WILL NOT BE SENT TO THE MANUFACTURER FOR REVIEW. ADDITIONAL ATTEMPTS TO CONTACT THE PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE. THE VNS WAS NOT DISABLED AT THE PHYSICIAN'S DISCRETION DESPITE MANUFACTURER'S RECOMMENDATION TO DO SO.

    Description of Event or Problem · 1

    THE PATIENT HAD A FULL REPLACEMENT SURGERY ON (B)(6) 2013. THE LEAD PIN WAS REINSERTED INTO THE GENERATOR BEFORE THE LEAD WAS EXPLANTED. THE SYSTEM DIAGNOSTICS AFTER RE-INSERTING STILL SHOWED HIGH IMPEDANCE WITH DCDC = 7.

    Description of Event or Problem · 1

    THE PATIENT'S SURGERY HAS BEEN SCHEDULED; HOWEVER, HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED ON 07/15/2013 WHICH PROVIDED THE PATIENT'S IMPLANTED VNS LEAD INFORMATION. THE DEVICE HISTORY REPORT WAS REVIEWED AND NO UNRESOLVED NON CONFORMANCES WERE FOUND.

    Description of Event or Problem · 1

    NEW INFORMATION REVEALED THAT THE PATIENT WAS REFERRED FOR A FULL REVISION AND THE X-RAYS WERE SENT TO THE SURGEON. THE SURGEON NOTED NO ANOMALIES HOWEVER THE POSSIBILITY OF A MICRO-FRACTURE WAS STILL POSSIBLE. THE PHYSICIAN DECIDED TO LEAVE THE PATIENT¿S VNS GENERATOR ON REGARDLESS OF THE MANUFACTURER RECOMMENDATION TO TURN THE GENERATOR OFF TO 0MA. ACCORDING TO THE PHYSICIAN THE PATIENT IS NOT EXPERIENCING ANY ADVERSE EVENTS. NEW INFORMATION RECEIVED REVEALED THAT THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE OR ON (B)(6) 2013 FOR HIS PROCEDURE BUT THE SURGERY WAS POSTPONED. THE PATIENT'S SURGERY IS UNKNOWN TO DATE.

    Description of Event or Problem · 1

    THE PATIENT¿S EXPLANTED LEAD AND GENERATOR WERE DISCARDED FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136517 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS, INC. 302-20 200335

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR