BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3790039 · Received May 5, 2014

    Report

    Report Number
    1644487-2014-01186
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT OR DATE OF BIRTH; CORRECTED DATA: ADDITIONAL INFORMATION INDICATES THAT THE DATE OF BIRTH IS (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. THE PATIENT HAS NOT HAD HIS DEVICE TESTED RECENTLY AND HAS NOT BEEN SEEN BY A NEUROLOGIST. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE VNS PATIENT¿S GENERATOR WAS REPLACED PROPHYLACTICALLY. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268487 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201224

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention