BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2250625 · Received September 16, 2011

    Report

    Report Number
    1644487-2011-02183
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    January 15, 2009
    Report Date
    August 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED WHEN THE PHYSICIAN REPORTED THAT THE INFECTION WAS FIRST NOTICED IN (B)(6) 2009. THE INFECTION WAS AT THE LEAD INSERTION SITE. THE VNS WAS THEN REMOVED IN (B)(6) 2009. THE INFECTION WAS A DIRECT WOUND INFECTION FROM THE VNS SURGERY.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A VNS TREATING PHYSICIAN REPORTED THAT THE VNS PATIENT HAD THEIR DEVICE EXPLANTED ON (B)(6) 2009. THE INFECTION WAS LOCATED AT THE NECK OF THE VNS INSERTION SITE AND WAS FIRST OBSERVED ON (B)(6) 2009. THEY DRAINED IT IN THE EMERGENCY ROOM ON (B)(6) 2009. THE PATIENT HAD 10 DAYS OF BACTRIM AND THEN DEVELOPED A GRANULOMA. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE INFECTION. CULTURES WERE TAKEN ON (B)(6) 2009 AND THE INFECTION WAS FOUND TO BE A (B)(6). THE PATIENT WENT FOR EXPLORATORY SURGERY ON (B)(6) 2011. THE OPERATION REPORT REVEALED THAT THE SURGEON FOUND A POSTULE OF THE LATERAL ASPECT OF HER CERVICAL INCISION FROM PLACEMENT OF THE VNS ELECTRODES. HE INCISED AROUND THIS WITH SOME DRAINAGE OF PUS. THE DISSECTION CONTINUED DOWN THROUGH THE SUPERFICIAL TISSUES AND WHERE THE TIE DOWNS FOR THE VNS WERE LOCATED. HE DISSECTED AROUND THIS AREA AND COULD FIND NO OTHER POCKETS OF PUS. HE COPIOUSLY IRRIGATED THE WOUND WITH BACITRACIN. HE LEFT THE VNS IMPLANTED AND REPORTED THAT HOPEFULLY IT WAS A SUPERFICIAL INFECTION. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN A STABLE CONDITION. THE PATIENT'S VNS WAS THEN EXPLANTED ON (B)(6) 2009 DUE TO THE INFECTION. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 200704

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention