BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 1102480 · Received August 8, 2008

    Report

    Report Number
    1644487-2008-01806
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    January 1, 2000
    Report Date
    July 8, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANDRIOLA MR, ROSENWEIG T, VLAY S. "VAGUS NERVE STIMULATION (VNS): INDUCTION OF ASYSTOLE DURING IMPLANTATIONS WITH SUBSEQUENT SUCCESSFUL STIMULATION." EPILEPSIA 2000;41(SUPPL.7):223. ABSTRACT: RATOINALE: A 54-YEAR OLD WOMAN EXPERIENCED AN ASYSTOLE DURING LEAD TESTING OF THE VNS IN THE OPERATING ROOM (OR). THE DEVICE WAS LEFT OFF, SHE UNDERWENT CARDIAC EVALUATION AND THEN UNDER CARDIAC MONITORING WAS UNEVENTFULLY STIMULATED AND REMAINS ON CHRONIC STIMULATION. METHODS: THE RECORDS OF 3 OTHER PATIENTS WITH BRADYCARDIA OR ASYSTOLES DURING LEAD TESTING IN THE OR WHO SUBSEQUENTLY UNDERWENT UNEVENTFUL STIMULATION WERE REVIEWED. RESULTS: A MAN WITH A STATIC ENCEPHALOPATHY HAS BEEN REPORTED WHO AFTER INITIAL CARDIAC ASYSTOLE WAS RECHALLENGED WITH A GRADUAL INCREASE IN INTENSITY OF THE STIMULUS BEFORE LEAVING THE OR. HE WAS REPORTED BY TATUM ET AL. (NEUROLOGY 1999;52:1267-69). A WOMAN WITH INTRACTABLE SEIZURES, DEPRESSION, DIABETES, AND HYPERTENSION EXPERIENCED AN ASYSTOLE IN THE OR WITH SUBSEQUENT STIMULATION INITIATED 2 WEEKS LATER. A MALE WITH ASYSTOLE IN THE OR HAS SUBSEQUENTLY BEEN CHRONICALLY STIMULATED. CONCLUSIONS: OF THE PATIENTS WORLD WIDE IMPLANTED WITH THE VNS, SOME HAVE BEEN REPORTED TO EXPERIENCE AN ASYSTOLE DURING INTRAOPERATIVE LEAD TESTING AT 1 MAMP. SOME OF THESE PATIENTS WERE SUBSEQUENTLY SAFELY CHRONICALLY STIMULATED WHILE 4 WERE EXPLANTED. MANUFACTURERS LABELING RECOMMENDS WAITING 2 WEEKS AFTER SURGERY BEFORE STIMULATION IS INITIATED. NOT ALL INVESTIGATORS AGREE. THIS REVIEW SUGGESTS THAT PATIENTS WHO EXPERIENCE BRADYCARDIA OR ASYSTOLE IN THE OR CAN SAFELY UNDERGO CHRONIC STIMULATION AND NEED NOT BE IMMEDIATELY EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE REVIEWED BY MANUFACTURER THAT THE VNS PATIENT EXPERIENCED AN ASYSTOLE EVENT INTRA-OPERATIVELY UPON INITIAL IMPLANTATION OF THE VNS DEVICE, DURING LEAD TEST. THE FOLLOWING IS THE SUMMARY OF THIS PATIENTS EVENT ACCORDING TO THE INFORMATION IN THE REFERENCED ARTICLE. A 54-YEAR OLD WOMAN EXPERIENCED ASYSTOLE DURING LEAD TESTING OF THE VNS IN THE OPERATING ROOM. THE DEVICE WAS LEFT OFF, AND THE PATIENT UNDERWENT CARDIAC EVALUATION, AND THEN UNDER CARDIAC MONITORING WAS UNEVENTFULLY STIMULATED AND REMAINS ON CHRONIC STIMULATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE UNDERWAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening