BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3900436 · Received June 27, 2014

    Report

    Report Number
    1644487-2014-01616
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT SURGERY. CLINIC NOTES WERE RECEIVED INDICATING THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES WHILE SLEEPING. THE PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND DIAGNOSTIC RESULTS SHOWED NORMAL DEVICE FUNCTION AT THE TIME. THE PATIENT¿S MEDICATIONS WERE ADJUSTED DURING THE OFFICE VISIT. THE PATIENT WAS EXPERIENCING TWO TYPES OF SEIZURES. THE FIRST TYPE WAS FOCAL SEIZURES WITH SECONDARY GENERALIZATION. THE PATIENT¿S HEAD WOULD FORCEFULLY DEVIATE TO THE RIGHT SIDE AND THE PATIENT WOULD RAISE HIS RIGHT ARM AND TENSE UP. THESE SEIZURES LASTED 2-3 MINUTES WITH GENERALIZED RHYTHMIC JERKING APPROXIMATELY ONCE OR TWICE PER MONTH. THE SECOND TYPE OF SEIZURE WAS SIMPLE-PARTIAL SEIZURES WHICH WOULD BECOME COMPLEX-PARTIAL SEIZURES. THE PATIENT WOULD START TO STARE AND BECOME UNAWARE OF HIS SURROUNDINGS. THESE SEIZURES LASTED APPROXIMATELY TWO MINUTES WITH THE PATIENT BEING UNRESPONSIVE AND MOTIONLESS AND OCCURRED A FEW TIMES EACH WEEK. THE PATIENT CONTINUED TO HAVE FREQUENT SEIZURES DESPITE MULTIPLE MEDICATIONS AND VNS. THE PATIENT¿S DEVICE SETTINGS HAVE NOT CHANGED SINCE AT LEAST (B)(6) 2013. THE RELATIONSHIP BETWEEN THE PATIENT¿S INCREASE IN SEIZURES AND PRE-VNS BASELINE LEVELS IS UNKNOWN. A BATTERY LIFE CALCULATION USING THE AVAILABLE PROGRAMMING HISTORY SHOWED APPROXIMATELY 1.59 YEARS UNTIL ERI = YES. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT UNDERWENT PROPHYLACTIC GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014. THE EXPLANTED GENERATOR HAS NOT BEEN RETURNED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377126 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 018240

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention