BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3111419 · Received May 14, 2013

    Report

    Report Number
    1644487-2013-01363
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INADVERTENTLY DID NOT INCLUDE THE EXPLANT DATE EVEN THOUGH IT WAS KNOWN AT THAT TIME.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. THERE WAS SOME DISCUSSION THAT THE GENERATOR MANY BE DEPLETED BASED ON HOW LONG IT HAD BEEN IMPLANTED BUT THIS WAS NOT ABLE TO BE CONFIRMED. THE PATIENT DID HAVE MONOPOLARCAUTERY SHORTLY BEFORE THE REPORT OF THE INCREASE IN SEIZURES AND THAT WAS THOUGHT IT COULD HAVE POSSIBLE DAMAGED THE GENERATOR ALSO. THE PATIENT THE PATIENT WAS HAVING A PULMONARY CONDITION, NOT RELATED TO VNS, WHICH COULD BE AFFECTING THE PATIENT'S SEIZURES. A BATTERY LIFE CALCULATION WAS PERFORMED AND SHOWED THAT THE PATIENT WAS AT OR NEAR END OF SERVICE. THE PATIENT HAD A GENERATOR REPLACEMENT AND THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. THE GENERATOR WAS CONFIRMED TO BE AT END OF SERVICE DUE TO NORMAL BATTERY DEPLETION. THE DEPLETION WAS AN EXPECTED EVENT AS DETERMINED BY THE BLC AND BATTERY VOLTAGE MEASUREMENT. THE MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE INCREASE IN SEIZURES WAS BELIEVED TO BE RELATED TO THE GENERATOR BEING AT END OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212628 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 015644

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR