BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 3031717 · Received April 2, 2013

    Report

    Report Number
    1644487-2013-00886
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 9, 2013
    Report Date
    March 4, 2013
    Manufacturer
    CYBERONICS
    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

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BOTH THE VNS LEAD AND GENERATOR EXPLANTED BECAUSE OF INFECTION ON (B)(6) 2013. ATTEMPTS TO CONTACT THE PHYSICIAN FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. ATTEMPTS TO RETURN THE PRODUCT TO THE MANUFACTURER HAVE BEEN UNSUCCESSFUL TO DATE. THE DEVICE HISTORY REPORT WAS REVIEWED FOR THE LEAD AND NO NON CONFORMANCES WERE FOUND. STERILITY WAS CHECKED AND REVIEWED ON (B)(6) 2013. THE VNS GENERATOR'S DEVICE HISTORY REPORT WAS NOT CHECKED SINCE THE VNS GENERATOR'S MODEL AND SERIAL NUMBER FOR THE PATIENT IN UNKNOWN. ATTEMPTS FOR PRODUCT INFORMATION ON THE VNS GENERATOR HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133673 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention