BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3251312 · Received July 29, 2013

    Report

    Report Number
    1644487-2013-02244
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 3, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WITH AN EVENT DATE OF (B)(6) 2013 THAT CHANGES THIS FIELD. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION.

    Description of Event or Problem · 1

    ON (B)(4) 2013, ADDITION INFORMATION WAS RECEIVED. THE ¿BATTERY STARTING TO FAIL¿ WAS CLARIFIED TO MEAN THAT THE DCDC CODE WAS 3. THE PATIENT BEGAN EXPERIENCING AN INCREASE IN SEIZURES ON (B)(6) 2013 PER A TELEPHONE MESSAGE. THE INCREASE IN SEIZURES IS ABOVE THE PRE-VNS BASELINE. INVENTIONS INCLUDED GENERATOR REVISION. ADDITIONAL INFORMATION PROVIDED BUT WAS ILLEGIBLE. IT WAS UNKNOWN IF, PRIOR TO INCREASING THE OUTPUT CURRENT, THE PATIENT COULD FEEL MAGNET MODE STIMULATION. THE PHYSICIAN DID NOT KNOW IF THE PATIENT BECAME USED TO THE SETTINGS RESULTING IN THE DECREASED PERCEPTION OF STIMULATION. SETTINGS AND DIAGNOSTICS FROM THE PATIENT¿S (B)(6) 2013 APPOINTMENT WERE PROVIDED INDICATING NORMAL FUNCTION.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 REVEALED THAT THE PATIENT APPEARED FOR A FOLLOW-UP NEUROLOGY APPOINTMENT. THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURE FREQUENCY FOR WHICH THE PHYSICIAN NOTED ¿THE VAGUS NERVE STIMULATOR MAY HAVE LOST ITS EFFECTIVENESS BECAUSE OF THE INCREASE IN SEIZURES.¿ THE PHYSICIAN INTERROGATED THE VNS DEVICE, AND REPORTED THAT IT ¿SEEMS THAT THE BATTERY IS STARTING TO FAIL¿ SO THE OUTPUT CURRENT WAS INCREASED FROM 1.5MA TO 1.75MA AND MAGNET OUTPUT CURRENT WAS INCREASED FROM 1.0MA TO 1.75MA. DIAGNOSTICS WERE PERFORMED AT 1.5MA INIDICATING THE NORMAL MODE DIAGNOSTICS WERE PERFORMED AND DCDC=3. THE PHYSICIAN NOTED THAT THE DCDC WAS ELEVATED, ¿SUGGESTIVE OF THE BATTERY FAILING.¿ HOWEVER, A DCDC=3 IS WITHIN NORMAL LIMITS AND ON NORMAL MODE DIAGNOSTICS DOES NOT SHOW THAT THE DEVICE IS WORKING HARDER TO DELIVER THE INTENDED THERAPY. THE DEVICE REPORTEDLY READ ¿END OF SERVICE.¿ THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT SURGERY. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THIS VNS PATIENT UNDERWENT GENERATOR REVISION.

    Description of Event or Problem · 1

    ON (B)(4) 2014, ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED GENERATOR WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353977 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 010504

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention