BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3130051 · Received May 24, 2013

    Report

    Report Number
    1644487-2013-01593
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 29, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD A RECENT FLURRY OF ABSENCE SEIZURES FOLLOWED BY CLUSTER OF GENERALIZED TONIC CLONIC SEIZURES. THE PHYSICIAN DID NOT SEE A CLEAR CAUSE OF EXACERBATION OF THE SEIZURES AND FEELS THAT IT MAY BE A LOW VNS BATTERY OR CONFUSING MEDICATIONS. THE PATIENT'S GENERATOR WAS NOT AT END OF SERVICE AT THE TIME SO A LOW BATTERY WOULD NOT HAVE BEEN THE CAUSE. THE PHYSICIAN DID NOT PROVIDE ANY ADDITIONAL INFORMATION WHEN ASKED. THE PATIENT HAD A RECENT GENERATOR REPLACEMENT AND THE GENERATOR HAD NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE GENERATOR WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS THE HOSPITAL DOES NOT RETURN EXPLANTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231572 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 200900

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention