BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3083430 · Received April 29, 2013

    Report

    Report Number
    1644487-2013-01197
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    September 1, 2009
    Report Date
    April 2, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2013. THE GENERATOR WAS RETURNED TO DEVICE MANUFACTURER ON (B)(4) 2013. THE RETURNED PRODUCT FORM INDICATED THAT THE GENERATOR WAS REPLACED DUE TO END OF SERVICE. THE END OF SERVICE ERI = YES BOX WAS CHECKED. THE GENERATOR ANALYSIS WAS COMPLETED ON (B)(4) 2013. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS IN THE PA LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 NOTED THAT THE PATIENT WAS HOSPITALIZED IN (B)(6) 2009 AFTER HAVING FREQUENT SEIZURES. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE IN HOUSE PROGRAMMING DATA WAS REVIEWED, WHICH IDENTIFIED THAT THE DEVICE PROGRAMMING SETTINGS WERE NOT ADJUSTED AROUND THE TIME OF THE REPORTED EVENT AND THAT DIAGNOSTICS WERE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184807 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 010024

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization