BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2942175 · Received February 4, 2013

    Report

    Report Number
    1644487-2013-00273
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    August 1, 2012
    Report Date
    January 12, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. AGE, CORRECTED DATA: THE PATIENT'S AGE WAS UPDATED FROM THE INITIAL REPORT DUE TO NEW INFORMATION RECEIVED. DATE OF EVENT, CORRECTED DATA: THE DATE OF EVENT WAS CORRECTED WITH NEW INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. DEVICE MANUFACTURING RECORDS WERE REVIEWED. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. REVIEW OF MANUFACTURING RECORDS OF THE LEAD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. SERIAL #, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED WRONG SERIAL NUMBER. LOT #, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED WRONG LOT NUMBER. EXPIRATION DATE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED WRONG EXPIRATION DATE. MANUFACTURE DATE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED WRONG MANUFACTURE DATE.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE GENERATOR WAS PROGRAMMED OFF ON (B)(6) 2013 WHEN THE HIGH IMPEDANCE WAS OBTAINED.

    Description of Event or Problem · 1

    ANALYSIS OF THE LEAD ASSEMBLY IDENTIFIED A CUT IN THE NEGATIVE COIL. ALTHOUGH, NOT CONCLUSIVE, IT APPEARS THIS OBSERVED CONDITION IS THE RESULT OF THE EXPLANT PROCEDURE. THE ELECTRODE ARRAY PORTION WAS NOT RETURNED FOR ANALYSIS. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATION, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. ANALYSIS OF THE GENERATOR IDENTIFIED NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS. THE GENERATOR ANALYSIS; HOWEVER, DID SHOW A GREATER THAN 55% CHANGE IN IMPEDANCE VALUE IN (B)(6) 2012. THIS IS LIKELY WHEN THE LEAD DISCONTINUITY OCCURRED.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PATIENT WAS SCHEDULED FOR REVISION SURGERY DUE TO HIGH IMPEDANCE. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT UNDERWENT LEAD AND GENERATOR REPLACEMENT DUE TO A LEAD DISCONTINUITY. IT WAS REPORTED THAT X-RAYS WERE TAKEN AND REVEALED A BREAK IN THE LEAD. BOTH THE LEAD AND GENERATOR ARE EXPECTED TO BE RETURNED TO DEVICE MANUFACTURER FOR ANALYSIS; HOWEVER, THE PRODUCTS HAVE NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE NURSE PRACTITIONER INDICATED THAT THERE WAS NO PATIENT MANIPULATION OR TRAUMA THAT OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE IMPLANT CARD WAS RECEIVED BY DEVICE MANUFACTURER INDICATING THAT BOTH THE LEAD AND GENERATOR WERE EXPLANTED ON (B)(6) 2013. THE LEAD IMPEDANCE WAS NOTED TO BE "OK" WITH THE NEW GENERATOR AND LEAD. X-RAYS WERE SENT TO DEVICE MANUFACTURER FOR REVIEW. BASED ON THE X-RAYS IMAGES RECEIVED, THERE ARE NO GROSS LEAD FRACTURES THAT CAN BE VISUALIZED. HOWEVER, THE PRESENCE OF AN UNPRONOUNCED LEAD DISCONTINUITY CANNOT BE RULED OUT. THE LEAD AND GENERATOR WERE RETURNED FOR ANALYSIS ON (B)(6) 2013; HOWEVER, PRODUCT ANALYSIS IS STILL UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47024 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200950

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR