BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2160568 · Received July 6, 2011

    Report

    Report Number
    1644487-2011-01504
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 9, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFG RECORDS WERE REVIEWED. REVIEW OF MFG RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO OUR DISTRIBUTOR IN (B)(4) THAT THERE WAS A VNS PT WHO HAS AN INFECTION. IT WAS REPORTED THAT THE PARENTS NOTICED THAT PT'S LEFT NECK SKIN BECAME RED AND SWOLLEN. THE SWELLING EXTENDED TO THORAX. THE PT HAD AN OPERATION ON (B)(6) 2011 TO DRAIN THE PUS, IN ADDITION TO ANTIBIOTIC MEDICATION THERAPY. THEY HAD A TOTAL OF 5 SURGERIES TO DRAIN PUS. THE DIAGNOSIS IS (B)(6) INFECTION, ANTIBIOTIC RESISTANT BACTERIAL INFECTION. THE INFECTION CONDITION HAS NOT RESOLVED AND A DECISION TO REMOVE THE GENERATOR AND LEAD HAS BEEN MADE. THE PT'S PHYSICIAN DOES NOT THINK THEIR INFECTION WAS VNS RELATED. THE INFECTED WOUND HE SUSPECTS FROM MOSQUITO BITE, WHICH PT SCRATCHED AND HAD AN OPEN WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2569

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| R