BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 3042390 · Received April 9, 2013

    Report

    Report Number
    1644487-2013-00953
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    February 10, 2013
    Report Date
    March 12, 2013
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF MANUFACTURING HISTORY RECORDS PERFORMED. REVIEW OF MANUFACTURING HISTORY RECORDS OF THE LEAD CONFIRMED THAT ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED AND MAY HAVE CONTRIBUTED TO THE VOCAL CORD PARALYSIS.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT, CORRECTED DATA:THE INITIAL REPORT INADVERTENTLY REPORTED THE PATIENT'S AGE AT THE TIME OF THE EVENT INCORRECTLY.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED FOR THE PATIENT'S FULL REVISION SURGERY. NOTES DATED (B)(6) 2013 REPORTED THAT THE PATIENT WAS LAST SEEN IN THE CLINIC ON (B)(6) 2012 AND SINCE HAD DEVELOPED A FRACTURE IN HIS VNS LEAD. HIS MOTHER HAD NOTED A SUDDEN CHANGE IN THE PATIENT'S VOICE ON (B)(6) 2013, AND HE WAS BROUGHT INTO CLINIC TO SEE THE NURSE PRACTITIONER ON (B)(6) 2013. INTERROGATION OF HIS VNS DEVICE DOCUMENTED A LEAD IMPEDANCE OF >9000 OHMS, INDICATING A LEAD FRACTURE NOTED FROM THE PHYSICIAN. THE OUTPUT CURRENT OF THE DUTY CYCLE AND MAGNET ACTIVATION CYCLE WERE SET TO ZERO, AND THE PATIENT WAS SCHEDULED FOR A LEAD REPLACEMENT. PER THE TREATING PHYSICIAN'S NOTES, THE SURGEON NOTED THAT THE PATIENT HAD A LEFT VOCAL CORD PARALYSIS AND WAS BEING TREATING WITH CORTICOSTEROIDS. THE PATIENT WAS HAVING REGULAR DAILY ABSENCE SEIZURES DESPITE SEVERAL CHANGES IN HIS ANTIEPILEPTIC MEDICATIONS UNTIL THREE WEEKS PRIOR WHEN THE SEIZURES STOPPED COMPLETELY, AND HE WAS SEIZURE-FREE UPON THE VISIT ON (B)(6) 2013. PRIOR, THE PATIENT HAD NEVER GONE A DAY WITHOUT A SEIZURE SINCE THEY BEGAN. PREVIOUSLY, THE PATIENT HAD BEEN PROGRAMMED TO RECEIVE 1.75 MA FOR 30 SECONDS EVERY 3 MINUTES WITH MAGNETIC ACTIVATION OF 2 MA FOR 60 SECONDS. HE HAD BEEN TOLERATING STIMULATION WITHOUT INCIDENT; HOWEVER "WITH THE LEAD FRACTURE, HE NOW HAS A LEFT VOCAL CORD PARALYSIS". IN THE NOTES DATED (B)(6) 2012, THE PATIENT PRESENTED WITH THE LAST VISIT ON (B)(6) 2012. THE PATIENT CONTINUED TO HAVE REGULAR, FREQUENT DAILY ABSENCE SEIZURES. THE PATIENT WAS HAVING THE SEIZURES MORE IN CLUSTERS THAT SPREAD OUT OVER THE COURSE OF THE ENTIRE DAY. THE PATIENT WAS TOLERATING VNS STIMULATION WITHOUT INCIDENT AT THIS TIME AT 1.75 MA. THE PATIENT'S ONFI AND VNS SETTINGS WERE INCREASED ON THIS VISIT. FOLLOW UP WITH THE TREATING PHYSICIAN REVEALED THAT NO PATIENT MANIPULATION OR TRAUMA IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE LEAD FRACTURE/HIGH LEAD IMPEDANCE. AS OF (B)(6) 2013, THERE WAS LITTLE CHANGE IN THE PATIENT'S VOCAL CORD PARALYSIS WITH TREATMENT WITH CORTICOSTEROIDS. THE PHYSICIAN DID NOT TAKE X-RAYS OF THE PATIENT'S VNS SYSTEM. THE PATIENT HAD LEAD REPLACEMENT SURGERY ON (B)(6) 2013. ATTEMPTS FOR PRODUCT RETURN ARE UNDERWAY, BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE GENERATOR AND LEAD REPLACEMENT INFORMATION WAS RECEIVED FROM THE HOSPITAL FACILITY WHICH CONFIRMED THAT THE PATIENT HAD GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2013. PRODUCT ANALYSIS OF THE GENERATOR WAS COMPLETED. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY SHOWS A NON-IFI (INTENSIFIED FOLLOW UP) CONDITION. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    THE PATIENT'S GENERATOR WAS RECEIVED BY THE MANUFACTURER FOR ANALYSIS ON (B)(6) 2013. THE RETURN PRODUCT FORM INDICATED THE REASON FOR REPLACEMENT AS END OF SERVICE (BATTERY DEPLETION). THE LEAD WAS NOT RETURNED FOR ANALYSIS. PRODUCT ANALYSIS OF THE EXPLANTED GENERATOR HAS NOT BEEN COMPLETED TO DATE. THEREFORE, THE PATIENT HAD GENERATOR AND LEAD REPLACEMENT ON (B)(6) 2013.

    Description of Event or Problem · 1

    ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146601 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 201776

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention