BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 3971858 · Received July 31, 2014

    Report

    Report Number
    1644487-2014-01898
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 20, 2013
    Report Date
    July 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF MANUFACTURE; CORRECTED DATA: THIS INFORMATION WAS INADVERTENTLY REPORTED INCORRECTLY ON THE INITIAL MFR. REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS OF THE GENERATOR CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    CLINIC NOTES DATED 06/20/2013 INDICATED THAT THE PHYSICIAN WAS UNABLE TO INTERROGATE THE PATIENT'S VNS. THE PATIENT HAS RECENTLY BEEN REFERRED FOR SURGERY. NO OTHER INFORMATION REGARDING THE VNS WAS INCLUDED IN THE CLINIC NOTES. FOLLOW UP DETERMINED THAT THE PATIENT HAD BEEN REFERRED FOR SURGERY CONSULT. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. NO KNOWN SURGICAL INTERVENTION HAS BEEN PERFORMED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY. THE EXPLANTING FACILTY DISCARDED THE EXPLANTED GENERATOR; THEREFORE, PRODUCT ANALYSIS CANNOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446847 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 102 2098

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR