BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2180925 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01658
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 27, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE VNS IMPLANTING SURGEON REPORTED THAT THE VNS PT HAD HIS VNS EXPLANTED ON (B)(6), 2011 DUE TO AN (B)(6) INFECTION. THEY WERE UNAWARE OF ANY PLANS TO REPLACE IT. THE SURGEON'S NURSE REPORTED THAT THE VNS PT WENT TO THE ER ON (B)(6), 2011 FOR SWELLING AND PAIN OF THE INCISION SITES ON THE NECK AND CHEST. THE PT WAS THEN PLACED ON ORAL ANTIBIOTICS. ON (B)(6), 2011, THE PT SAW THEIR SURGEON AND THE INFECTION HAS NOT GOTTEN ANY BETTER SINCE THEIR ER VISIT TWO DAYS PRIOR. THE SURGEON PRESCRIBED STRONGER ANTIBIOTICS AND EXPLAINED TO THE PT THAT IF THEY DON'T FEEL BETTER IN 12-24 HRS, TO VISIT THE SURGEON AGAIN. THE PT WAS HOSPITALIZED ON (B)(6), 2011 FOR THE INFECTION AND PLACED ON IV ANTIBIOTICS OF VANCOMYCIN AND AOSYN. CULTURES OF BOTH SITES WERE TAKEN AT THAT TIME AND THE INFECTION WAS DISCOVERED TO BE (B)(6). THE PT WAS EXPLANTED ON (B)(6), 2011 BECAUSE OF THE INFECTION. THE SURGEON'S NURSE REPORTED THAT IT IS UNCLEAR AT THIS TIME IF THE INFECTION IS RELATED TO THE VNS DEVICE OR A PROBLEM WITH THE SURGERY. THE PT IS VERY ALERT AND DID NOT TOUCH OR SCRATCH THE SITE AND NO TRAUMA WAS NOTED THAT COULD HAVE CAUSED/CONTRIBUTED TO THE INFECTION. REVIEW OF THE MFG RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION. IF FURTHER INFO IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 2749

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R