BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3920194 · Received July 8, 2014

    Report

    Report Number
    1644487-2014-01731
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 18, 2014
    Report Date
    June 12, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 RECENTLY IMPLANTED VNS PATIENT DEVELOPED A STAPH INFECTION AT HIS GENERATOR AND LEAD SITES FROM SCRATCHING THE INCISIONS. THE PATIENT¿S LEAD INCISION BEGAN TO OPEN BUT THERE WERE NO REPORTS OF LEAD EXTRUSION. THE PATIENT WAS GIVEN ANTIBIOTICS. THE PATIENT WENT TO THE ER ON (B)(6) 2014 AND THE ER PHYSICIAN STATED THAT THE PATIENT¿S INCISION SITES LOOKED OK. CLINIC NOTES WERE RECEIVED INDICATING THAT THE PATIENT HAD SOME DRAINAGE AND GRANULATION TISSUE AT THE LEAD INCISION. CULTURES WERE POSITIVE FOR STAPH INFECTION. THERE WAS NO SIGN OF FLUCTUATION OR PUS. THE CHEST INCISION HAD HEALED. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT WAS RE-EVALUATED BY A DIFFERENT PHYSICIAN AND DIAGNOSED WITH CELLULITIS. THE PATIENT¿S ANTIBIOTICS WERE ADJUSTED. NO DRAINAGE OR FURTHER INTERVENTION WAS REQUIRED. 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 PICKED OPEN THE NECK INCISION AGAIN. THE PHYSICIAN PLANS TO MOVE THE LEAD TOWARD THE BACK OF HIS NECK. THE PATIENT HAS BEEN SEIZURE FREE SINCE VNS IMPLANT, SO THE PATIENT'S PARENTS DO NOT WANT THE DEVICE EXPLANTED. NO KNOWN SURGICAL INTERVENTIONS HAVE BEEN PERFORMED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NECK INCISION IS OPEN AND DRAINING AND CULTURES CAME BACK NEGATIVE. THE PATIENT WAS SCHEDULED FOR SURGERY TO CLOSE THE INCISION UNDER SEDATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PICKED OPEN THE CHEST SITE AGAIN, SO THE PLAN WAS TO HAVE SURGERY TO CLOSE IT. SURGERY OCCURRED AS SCHEDULED ON (B)(6) 2014; THE INCISION WAS CLOSED. OPERATIVE NOTES FROM THE SURGERY ON (B)(6) 2014 REPORTED THAT THE DIAGNOSIS WAS INFECTED GENERATOR INCISION AND OPERATION PROCEDURE TO DEBRIDE THE INCISION SITE AND REPOSITION THE GENERATOR. THERE WAS PUS UNDER THE TEGADERM. THIS WAS ASPIRATED AND SENT FOR CULTURES FOR AEROBIC, ANAEROBIC, ACID FAST AND FUNGAL ORGANISMS. THERE WAS SOME MUCOID TISSUE SUSPECTED FOR INFECTION THAT WAS CLEANED. THIS WAS LOCATED IN THE LEFT CORNER OF THE INCISION. THE WOUND AND THE LEAD AND GENERATOR WERE THOROUGHLY CLEANED. BETADINE SOLUTION WAS USED TO CLEAN THE WOUND AND THE LEAD AND GENERATOR. THE DEVICES WERE CONNECTED AND SECURED. THE WOUND WAS CLOSED WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398052 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202782

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention