BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2895404 · Received January 3, 2013

    Report

    Report Number
    1644487-2013-00043
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    October 1, 2012
    Report Date
    December 6, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY ANOMALIES.

    Additional Manufacturer Narrative · 1

    PATIENT DID NOT HAVE FULL REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    EXPLANT DATE, CORRECTED DATA: SUPPLEMENTAL MDR #3 REPORTED THAT THE DEVICE WAS EXPLANTED; HOWEVER, IT WAS LATER FOUND AND REPORTED IN SUPPLEMENTAL MDR #4 THAT THE DEVICE WAS NOT EXPLANTED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING AND DEVICE DIAGNOSTIC HISTORY PERFORMED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED, WHICH INDICATES THAT THE VNS LEAD AND GENERATOR WERE REPLACED ON (B)(6) 2013. THE EXPLANTED DEVICE WILL NOT BE RETURNED, AS THEY WERE DISCARDED.

    Description of Event or Problem · 1

    A REVIEW OF THE DESIGN MANUFACTURING RECORDS OF THE PATIENT'S IMPLANTED LEAD AND GENERATOR WAS PERFORMED ON (B)(6) 2013 AND NO UNRESOLVED NON CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2013 AND UPON INTERROGATION THE FOLLOWING MESSAGE DISPLAYED. "WARNING, LEAD UNATTACHED FROM DEVICE." THE PATIENT'S NEUROLOGY OFFICE REPORTED THAT THE PATIENT'S DEVICE WAS TESTED AND A "HIGH LEAD IMPEDANCE WAS DETECTED"; UPON INTERROGATION. IT WAS REPORTED THAT THE PATIENT HAD JUST HAD A BRAND NEW UNIT PUT IN NOT MORE THAN A MONTH AGO. A DIAGNOSTIC TEST WAS RUN AND THE HIGH LEAD IMPEDANCE WARNING MESSAGE WAS SEEN AGAIN. THIS IS THE THIRD TIME THAT THE DEVICE HAS BEEN CHECKED SINCE IT WAS IMPLANTED ON (B)(6) 2013 AND THIS WARNING HAS NOT COME UP BEFORE. FURTHER INFORMATION WAS ATTAINED THAT THE PATIENT DID NOT HAVE FULL REVISION SURGERY IN (B)(6) 2013 AND THE LEAD WAS INITIALLY SUPPOSED TO BE REPLACED BUT DID NOT END UP NEEDING TO BE REPLACED BECAUSE THE DIAGNOSTIC TESTING WITH THE NEW GENERATOR WAS FINE. IT IS UNKNOWN AT THIS TIME IF THIS IS A POSITIONAL LEAD BREAK OR A LEAD PIN INSERTION ISSUE. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS ABOUT THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(4) 2012 THAT A VNS PATIENT EXPERIENCED AN INCREASE IN SEIZURES OVER THE LAST TWO MONTHS AND INTERROGATION OF THE PATIENT'S VNS DEVICE SHOWED A HIGH IMPEDANCE WARNING MESSAGE. DIAGNOSTICS WAS PERFORMED AND THE RESULTS CONFIRMED HIGH IMPEDANCE. THE PHYSICIAN STATED THAT THE DEVICE WAS INTERROGATED ONE MONTH PRIOR AND DID NOT INDICATE ANY WARNING MESSAGE. NO DIAGNOSTICS WERE PERFORMED ON THAT DAY. THE PHYSICIAN STATED THAT THE PATIENT IS HAVING SEIZURES AND DOES SOMETIMES FALL OUT OF THE BED BUT THERE WAS NOT ANY REPORTS OF TRAUMA AND THE PATIENT DOES NOT MANIPULATE THE DEVICE. THE PATIENT IS CURRENTLY BEING REFERRED FOR REVISION SURGERY HOWEVER SURGERY HAS NOT TAKEN PLACE. THE PATIENT'S PROGRAMMING AND DEVICE DIAGNOSTIC HISTORY AVAILABLE IN THE MANUFACTURER'S IN-HOUSE PROGRAMMING DATABASE WAS REVIEWED HOWEVER THE INFORMATION WAS ONLY AVAILABLE FOR THE DATE OF IMPLANT. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 INDICATING THAT THE INCREASED SEIZURES WERE FIRST NOTED IN (B)(6) 2012. X-RAYS WERE PERFORMED, HOWEVER THE FILMS WERE NOT SENT TO THE MANUFACTURER FOR REVIEW. TWO RADIOLOGY REPORTS WERE RECEIVED HOWEVER WHICH INDICATED THAT NO FRACTURE OR MAL-ALIGNMENT WAS NOTED. THE PHYSICIAN INDICATED THAT HE BELIEVED THE INCREASED SEIZURES WERE A RESULT OF THE FAILURE OF THE VNS UNIT. AS A RESULT, THE PHYSICIAN HAS HAD TO INCREASE THE PATIENT'S MEDICATIONS. THE PHYSICIAN REPORTED THAT THE PATIENT'S COMPLEX-PARTIAL GOING INTO GENERALIZED AS WELL AS HER COMPLEX PARTIAL WITHOUT GENERALIZATION HAVE BOTH INCREASED. THE PHYSICIAN NOTED THAT THE PATIENT HAD RECEIVED EFFICACY FROM THE DEVICE AND HAVE BEEN ABLE TO CUT BACK ON MEDICATION. THE PATIENT'S GENERATOR WAS DISABLED WHEN THE HIGH IMPEDANCE WAS NOTED. REVISION IS LIKELY BUT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE PHYSICIAN BUT NO FURTHER INFORMATION WAS RECEIVED. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    THE PATIENT HAD FULL REVISION SURGERY AND THEIR EXPLANTED PRODUCTS WERE DISCARDED THEREFORE NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1109

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other