BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2212668 · Received August 16, 2011

    Report

    Report Number
    1644487-2011-01875
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    May 4, 2011
    Report Date
    July 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AWARE DATE AS WELL AS THE DATE THAT THE IMPLANT CARD WAS RECEIVED SHOULD HAVE BEEN LISTED AS (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    (B)(6). THE AWARE DATE AS WELL AS THE DATE THAT THE IMPLANT CARD WAS RECEIVED SHOULD HAVE BEEN LISTED AS (B)(6) 2011.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 WHEN THE IMPLANT CARD WAS RECEIVED FROM THE HOSPITAL REPORTING THAT THE PATIENT'S LEAD IMPEDANCE AFTER SURGERY WAS WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 WHEN THE IMPLANT CARD WAS RECEIVED FROM THE HOSPITAL REPORTING THAT THE PATIENT'S LEAD IMPEDANCE AFTER SURGERY WAS WITHIN NORMAL LIMITS. THE MANUFACTURER'S CONSULTANT REPORTED THAT SHE MADE GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN CONCERNING THE PATIENT'S ADVERSE EVENTS. THE PHYSICIAN REPORTED THAT THE PATIENT IS DOING WELL AFTER THE GENERATOR REPLACEMENT AND THAT ALL THE PATIENT'S ISSUES HAVE RESOLVED EXCEPT FOR HER PRE-EXISTING CONDITIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 WHEN THE IMPLANT CARD WAS RECEIVED FROM THE HOSPITAL REPORTING THAT THE PATIENT'S LEAD IMPEDANCE AFTER SURGERY WAS WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, CLINIC NOTES FROM A VNS TREATING PHYSICIAN WERE RECEIVED THROUGH CASE MANAGEMENT. REVIEW OF THE CLINIC NOTES DATED (B)(6) 2011 REVEALED THAT THE PATIENT WAS EXPERIENCING PAIN IN THEIR CHEST WITH STIMULATION. THE PATIENT SAID THE PAIN IS SHARP AND IS AT THE INCISION LOCATION OF THE GENERATOR SITE. THE PATIENT WAS ALSO REPORTED TO BE EXPERIENCING SLEEP APNEA. THE PATIENT WAS RECENTLY EVALUATED BY AN EAR, NOSE, AND THROAT PHYSICIAN WHO DISCOVERED THAT THE PATIENT HAS PARALYSIS OF THE LEFT VOCAL CORD IN THE MEDIAN POSITION WHICH IS CAUSING THE PATIENT DYSPNEA AND COUGHING. THE PATIENT SAYS THAT THE VNS DOES HELP WITH SEIZURES AND THAT IF THE VNS IS OFF SHE WILL HAVE GRAND MAL SEIZURES. A 14-SYSTEM REVIEW OF THE PATIENT'S SYSTEMS WAS DONE BY THE PHYSICIAN AND THE PATIENT WAS FOUND TO HAVE ASTHMA. THE PATIENT'S SETTINGS WERE OUTPUT=2.75MA/FREQUENCY=30HZ/PULSE WIDTH=130USEC/ON TIME=30SEC/OFF TIME=1.8MIN/MAGNET OUTPUT=3MA/MAGNET ON TIME=60SEC/MAGNET PULSE WIDTH=130USEC. THE PHYSICIAN REPORTED THAT IF THE PATIENT'S SYMPTOMS PERSIST, IT MAY BE NECESSARY TO EXPLORE AND POSSIBLY REPLACE THE GENERATOR AS SHE GETS BENEFIT FROM A FUNCTIONING SYSTEM. CLINIC NOTES DATED (B)(6) 2011 REPORT THAT THE PATIENT HAS HAD AN INCREASE IN SEIZURE FREQUENCY OVER THE PAST FEW MONTHS. THE PATIENT HAS ALSO NOTICED AN INCREASED PAIN IN HER LEFT CHEST IN THE AREA OF THE GENERATOR POCKET. DIAGNOSTICS WERE PERFORMED WHICH REVEALED NO MALFUNCTION; SPECIFICS WERE NOT PROVIDED. THE PHYSICIAN REPORTED THAT GIVEN THE PATIENT'S PAIN IN HER CHEST, AS WELL AS DECREASED EFFICACY WITHIN THE PAST 3 MONTHS, HE IS REFERRING THE PATIENT FOR PROPHYLACTIC BATTERY REPLACEMENT. ADDITIONAL CLINIC NOTES WERE RECEIVED FROM THE PHYSICIAN DATED (B)(6) 2011 WHICH REVEALED THAT THE PATIENT WAS HAVING AN INCREASE IN SPELLS. THE PATIENT WENT TO THE EPILEPSY MONITORING UNIT AND THESE WERE NON-EPILEPTIC. THE PATIENT ALSO FEELS THAT HER ASTHMA HAS WORSENED. THE PATIENT'S SETTINGS WERE OUTPUT=2.75MA/FREQUENCY=30HZ/PULSE WIDTH=130USEC/ON TIME=30SEC/OFF TIME=1.8MIN/MAGNET OUTPUT=3MA/MAGNET ON TIME=60SEC/MAGNET PULSE WIDTH=130USEC. A BATTERY LIFE CALCULATION WAS PERFORMED WITH THE PATIENT'S PROGRAMMING HISTORY AND IT REVEALED NEGATIVE YEARS UNTIL ERI = YES. THE PATIENT WENT FOR BATTERY REPLACEMENT SURGERY ON (B)(6) 2011. THE MANUFACTURE'S CONSULTANT REPORTED THAT SHE HAS THE EXPLANTED GENERATOR AND WILL BE SENDING IT BACK FOR PRODUCT ANALYSIS BUT IT HAS NOT YET BEEN RECEIVED. WHEN ADDITIONAL INFORMATION HAS BEEN RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 WHEN THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS THAT WAS COMPLETED ON (B)(6) 2011. THE SEPTUM WAS NOT CORED, THUS ELIMINATING THE POSSIBILITY OF A POTENTIAL UNINTENDED ELECTRICAL CURRENT PATH THROUGH BODY FLUIDS. IN THE PRODUCT ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 010960

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention