BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2945092 · Received February 6, 2013

    Report

    Report Number
    1644487-2013-00294
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    October 19, 2012
    Report Date
    January 8, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    NEW INFORMATION REVEALED THAT THE PATIENT HAS UNDERGONE SURGERY ON (B)(6) 2013. THE VNS GENERATOR WAS EXPLANTED AND RETURNED TO THE MANUFACTURER ON (B)(6) 2013 FOR PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS FOR THE VNS GENERATOR WAS COMPLETED AND THE BATTERY WAS FOUND TO BE DEPLETED. THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INCREASE IN SEIZURES. A BATTERY LIFE CALCULATION WAS PERFORMED AND IT SHOWED THAT THE GENERATOR HAS 0 YEARS LEFT UNTIL ITS END OF SERVICE. ACCORDING TO THE PHYSICIAN THE INCREASE IN SEIZURES IS RELATED TO THE NEED OF THE GENERATOR TO BE REPLACED. HE ALSO STATED THAT THE INCREASES IN SEIZURES ARE ABOVE BASELINE AND THAT THE GRAND MAL SEIZURES HAVE INCREASED. ON (B)(6) 2013, NORMAL AND SYSTEM DIAGNOSTICS SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/DCDC=3. THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50353 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200989

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention