BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2213954 · Received August 17, 2011

    Report

    Report Number
    1644487-2011-01885
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    November 17, 2010
    Report Date
    July 26, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE MANUFACTURER'S CONSULTANT REPORTED THAT SHE HAS MADE GOOD FAITH ATTEMPTS TO THE PHYSICIAN REGARDING THE PATIENT'S HIGH IMPEDANCE, BUT HAS NOT RECEIVED ANY FURTHER INFORMATION BACK FROM THEM. IF MORE INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ON JULY 26, 2011, DURING REVIEW OF THE PATIENT'S PROGRAMMING HISTORY, IT WAS DISCOVERED THAT THE PATIENT HAD HIGH IMPEDANCE ON (B)(6) 2010; OUTPUT=LIMIT/LEAD IMPEDANCE=HIGH/DCDC=7/ERI=NO. A NORMAL MODE DIAGNOSTICS TEST PERFORMED THAT DAY SHOWED OUTPUT=LIMIT/LEAD IMPEDANCE=HIGH/DCDC=7/ERI=NO. ON (B)(6) 2011, THE PATIENT WAS DISABLED, MOST LIKELY FOR A MEDICAL PROCEDURE, AND THE PATIENT WAS PROGRAMMED BACK UP TO 2MA ON (B)(6) 2011. IT IS UNKNOWN IF THE POTENTIAL MEDICAL PROCEDURE POSSIBLY CAUSED TRAUMA TO THE VNS, THEREBY RESULTING IN HIGH IMPEDANCE. A NORMAL MODE DIAGNOSTICS TEST WAS RAN ON THE PATIENT'S PRIOR VISIT ON (B)(6) 2010 WHICH SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/DCDC=4/ERI=NO. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED NEGATIVE YEARS UNTIL ERI=YES. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION ARE UNDERWAY BY THE MANUFACTURER'S CONSULTANT BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ON (B)(4) 2011, ADDITIONAL INFORMATION WAS RECEIVED WHEN THE NURSE PRACTITIONER REPORTED THAT SHE WAS NOT AWARE THAT THE PATIENT HAD HIGH IMPEDANCE. SHE REPORTED THAT SHE CAN'T REMEMBER IF IT WAS HER OR THE PHYSICIAN WHO RAN THE DIAGNOSTICS FOR THIS PATIENT. THE CONSULTANT REPORTED THAT SHE WILL REVIEW HIGH IMPEDANCE AND WHAT TO LOOK FOR IN THE DIAGNOSTICS WITH THE NURSE PRACTITIONER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 7631

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR