BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3241380 · Received July 22, 2013

    Report

    Report Number
    1644487-2013-02212
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 26, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY DID NOT PROVIDE DETAILS ABOUT ANTIBIOTICS NOT HELPING TO RESOLVE THE INFECTION.

    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 LEAD EXPLANT SURGERY ON (B)(6) 2013. PUS WAS REPORTEDLY OOZING FROM THE GENERATOR SITE AND ANTIBIOTICS WERE UNSUCCESSFUL IN RESOLVING THE INFECTION. THEREFORE, THE GENERATOR WAS EXPLANTED ON (B)(6) 2013.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE VNS PATIENT WAS RE-IMPLANTED WITH A NEW GENERATOR AND LEAD ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON MENTIONED THAT THE ORIGINALLY IMPLANTED LEADS THAT WERE EXPLANTED WERE PLACED ON A SENSORY NERVE AND NOT ON THE VAGUS NERVE. ON (B)(6) 2013, THE PATIENT PRESENTED WITH REDNESS AT THE IMPLANT SITE AND THE PATIENT SUBSEQUENTLY LATER HAD GENERATOR REMOVED. THE PATIENT RETURNED TO THE NEUROSURGEON¿S OFFICE ON (B)(6) 2013 WITH DRAINAGE FROM THE INCISION SITE AND WAS ADMITTED TO THE HOSPITAL FOR WASHOUT ON (B)(6) 2013. SHE PRESENTED AT THE OTHER HOSPITAL ON (B)(6) 2013 FOR A SECOND OPINION AND THEN HAD THE LEAD EXPLANT ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S GENERATOR SITE WAS INFECTED. THERE WAS PUSS PRESENTS. ANTIBIOTICS WERE PRESCRIBED BUT DID NOT HELP AND THE GENERATOR WAS EXPLANTED. 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
    340891 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202372

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention