BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3022586 · Received March 27, 2013

    Report

    Report Number
    1644487-2013-00826
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED MDR INADVERTENTLY OMITTED THAT THE DEVICE WAS DISABLED ON (B)(6) 2013 AFTER HIGH IMPEDANCE WAS SEEN. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT HIGH IMPEDANCE WAS OBSERVED IN A SYSTEM DIAGNOSTIC (OUTPUT STATUS: LIMIT, IMPEDANCE: HIGH). THE DEVICE WAS LAST INTERROGATED ON (B)(6) 20112 WITH NORMAL RESULTS. THE PATIENT TYPICALLY FELL DURING SEIZURES WHICH MANY HAVE CONTRIBUTED THE EVENT. X-RAYS WERE TAKEN BUT WILL NOT BE PROVIDED FOR REVIEW. THERE WAS REPORTEDLY NO LEAD FRACTURE SEEN. ADDITIONAL INFORMATION WAS RECEIVED VIA CLINIC NOTES THAT THE PATIENT HAD AN INCREASE IN SEIZURES IN (B)(6) 2012, AND TWO EPISODES STATUS EPILEPTICUS: ONE IN (B)(6) 2012 AND ONE IN (B)(6) 2012. FOLLOW-UP SHOWED THAT THESE EVENTS WERE LIKELY NOT RELATED TO VNS. THE PATIENT ALSO EXPERIENCED AN INCREASE IN SEIZURES IN MARCH, BUT THIS WAS RELATED TO MEDICATION CHANGES. A BATTERY LIFE CALCULATION WAS PERFORMED WITH RESULTS OF 1.68 YEARS REMAINING. PROGRAMMING HISTORY SHOWED DIAGNOSTICS WITHIN NORMAL LIMITS FROM (B)(6) 2006 (DOI) TO (B)(6) 2012. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Description of Event or Problem · 1

    THE GENERATOR ONLY WAS RETURNED ON (B)(6) 2013. THE GENERATOR WAS EXPLANTED/RETURNED FOR ¿PROPHYLACTIC REPLACEMENT¿. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THIS PATIENT UNDERWENT FULL REVISION. THE DEVICES ARE PENDING RETURN.

    Description of Event or Problem · 1

    THE DEVICE WAS DISABLED ON (B)(6) 2013 AFTER HIGH IMPEDANCE WAS SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125972 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200200

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR