BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2962230 · Received February 14, 2013

    Report

    Report Number
    1644487-2013-00406
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 16, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    REPORTER INDICATED THAT A PATIENT HAD DEVELOPED A LOCALIZED INFECTION FOLLOWING INITIAL VNS IMPLANT SURGERY ON (B)(6) 2013. THE PATIENT HAD NOT TAKEN HER ANTIBIOTICS AS PRESCRIBED POSTOPERATIVELY. THE PATIENT WAS THEN GIVEN A PRESCRIPTION FOR DOXYCYCLINE ANTIBIOTIC.ATTEMPTS FOR ADDITIONAL INFORMATION AND VNS IMPLANT INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    REPORTER INDICATED THE REPORTED INFECTION WAS DUE TO A RESPIRATORY TRACT INFECTION. THE PATIENT HAD TRAUMA DUE TO PROLONGED COUGHING AS A RESULT OF THE UPPER RESPIRATORY INFECTION. THERE WAS NO ACTUAL INFECTION OF THE VNS SITE NOTED; ONLY ERYTHEMA. NO WOUND CULTURES WERE PERFORMED. THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS. THE PATIENT IS RECOVERING SATISFACTORILY FROM THE RESPIRATORY INFECTION. ALL ATTEMPTS FOR VNS PRODUCT INFORMATION FROM THE IMPLANTING HOSPITAL HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    VNS PRODUCT INFORMATION WAS OBTAINED FROM THE IMPLANTING HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64744 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 3490

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention