BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2243790 · Received September 12, 2011

    Report

    Report Number
    1644487-2011-02139
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVENT DATE, CORRECTED DATA: ADDITIONAL INFORMATION WAS RECEIVED WHICH CHANGES THE EVENT DATE THAT WAS REPORTED ON THE INITIAL REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011, WHEN THE PHYSICIAN PROVIDED CLINIC NOTES DATED (B)(6) 2010. THE CLINIC NOTES STATED THAT THE PATIENT'S SEIZURES HAVE GOTTEN WORSE AND THAT THE PATIENT'S MOTHER THINKS THE PATIENT HAD AN EPISODE WHERE HE SOMEHOW PUSHED ON HIS VNS AND CAUSED IT TO MIGRATE IN HIS CHEST. DURING CLINICAL VISIT THAT DAY HIGH IMPEDANCE WAS DISCOVERED. THE PATIENT'S SETTINGS THAT DAY WERE OUTPUT=2MA/FREQUENCY=20HZ/PULSE WIDTH=1000USEC/ON TIME=30SEC/OFF TIME=60SEC/MAGNET OUTPUT=2.75MA/MAGNET ON TIME=30SEC/MAGNET PULSE WIDTH=500USEC. THE PHYSICIAN LATER REPORTED THAT THE INCREASED SEIZURES WERE FIRST NOTICED IN (B)(6) OF 2010 AND DUE TO THE HIGH IMPEDANCE. THE RELATIONSHIP OF THE INCREASED SEIZURES TO PRE-VNS BASELINE LEVELS IS UNKNOWN. THE PATIENT HAS TONIC SEIZURE AND FACIAL MOTOR SEIZURES; BOTH OF WHICH INCREASED. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT YET OCCURRED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A VNS TREATING PHYSICIAN REPORTED THAT THE VNS PATIENT HAD HIGH IMPEDANCE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT YET OCCURRED. THE PROGRAMMING HISTORY DATABASE WAS SEARCHED AND A SYSTEM DIAGNOSTICS TEST PERFORMED ON (B)(6) 2010 SHOWED OUTPUT=LIMIT/LEAD IMPEDANCE=HIGH/DCDC=7/ERI=NO. THE PATIENT WAS LEFT PROGRAMMED TO OUTPUT=2MA/FREQUENCY=20HZ/ PULSE WIDTH=1000USEC/ON TIME=30SEC/OFF TIME=60MIN/MAGNET OUTPUT=2.75MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC THAT DAY AND WAS NOT DISABLED. ADDITIONAL INFORMATION REGARDING THE PATIENT'S HIGH IMPEDANCE HAS BEEN REQUESTED FROM THE PHYSICIAN, BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012, WHEN IT WAS DISCOVERED THAT THE PATIENT UNDERWENT A FULL REVISION SURGERY ON (B)(6) 2012, DUE TO HIGH LEAD IMPEDANCE. THE HOSPITAL REPORTED THAT THEY NO LONGER RETURN EXPLANTED PRODUCT S TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-30 31873C

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention