BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3223298 · Received July 12, 2013

    Report

    Report Number
    1644487-2013-02091
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 21, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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) 2013, IT WAS REPORTED THAT THE PATIENT DID NOT HAVE AN INFECTION. CULTURES WERE TAKEN THREE TIMES AND WERE NEGATIVE AND INCLUSIVE. THE PATIENT HAD WOUND DEHISCENCE, AND THE SKIN OVER THE GENERATOR WAS VERY THIN. THERE WAS BARELY ANY TISSUE LEFT WHEN THE PATIENT WAS SEEN (B)(6) 2013. THE WOUND OPENED, EXPOSING THE GENERATOR AS THEY WERE GOING IN FOR SURGERY (IN OR RIGHT BEFORE OR). THE PATIENT DID NOT HAVE THE GENERATOR REPLACED: THE GENERATOR WAS IMPLANTED DEEPER. SURGERY WAS ON (B)(6) 2013. THE CAUSE WAS UNKNOWN, BUT IT WAS LIKELY RELATED TO THE PATIENT¿S PHYSIOLOGY AND RESPONSE. NO KNOWN TRAUMA OR CHANGE THAT WOULD HAVE CAUSED THE ISSUE. THE PATIENT HAD NOT BEEN SEEN SINCE SURGERY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD A INFECTION AT THE GENERATOR SITE. THE PATIENT APPARENTLY HAD THE INFECTION FOR WEEKS. THE PATIENT WAS RECENTLY IMPLANTED (B)(6) 2013. THE PATIENT WAS HAVING SURGERY TO EITHER REVISE OR REMOVE THE VNS. IT HAS NOT BEEN CONFIRMED WHICH WAS DONE. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321972 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202301

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other| R