BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3193110 · Received June 27, 2013

    Report

    Report Number
    1644487-2013-01951
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    January 24, 2013
    Report Date
    June 4, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOW-UP REVEALED THAT THE EXPLANTED GENERATOR WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS AS IT SUSPECTED THAT THE DEVICE HAS BEEN DISCARDED AS THE CONTACT AT THE HOSPITAL DID NOT RECEIVE ANY REQUEST TO HAVE THE PRODUCT RETURNED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD AN INCREASE IN SEIZURES AND REQUESTED TO HAVE THE VNS EXPLANTED. FOLLOW-UP WITH THE PHYSICIAN INDICATED THAT THE INCREASE IN SEIZURES PER THE PATIENT HAS BEEN SINCE IMPLANT AND THE PATIENT REPORTED THAT HE IS HAVING UP TO 3 PER DAY. THE SEIZURE FREQUENCY PRIOR TO VNS WAS UNKNOWN. THE PATIENT ALSO HAD A GENERALIZED SEIZURE THE DATE FOLLOWING A SETTINGS CHANGE. ALTHOUGH THIS WAS NOT ABNORMAL THE PATIENT TYPICALLY HAS FOCAL SEIZURES. THE PATIENT IS STILL PERUSING EXPLANT. THE PHYSICIAN HAS NOT TRIED DISABLING THE PATIENT TO SEE IF THE ISSUE RESOLVED. EXPLANT IS PER THE PATIENT¿S REQUEST AND THAT IS WHY THEY ARE BEING REFERRED. NO FURTHER INFORMATION WAS PROVIDED. SURGERY IF LIKELY BUT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    THE PATIENT'S VNS GENERATOR WAS EXPLANTED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294228 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3233

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention