BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3023649 · Received March 27, 2013

    Report

    Report Number
    1644487-2013-00835
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    December 13, 2012
    Report Date
    February 28, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT DURING A VENTRAL HERNIA REPAIR SURGERY, A VNS PATIENT HAD AN EPISODE OF BRADYCARDIA. THE PATIENT DID NOT HAVE A HISTORY OF CARDIAC EVENTS, BUT THE PATIENT'S FATHER DID HAVE A HISTORY OF CARDIAC EVENTS. THE PATIENT HAS PRE-EXISTING MEDICAL CONDITIONS OF HYPERTENSION, DEPRESSION, ASTHMA, GERD, AND TMJ. THE ARRHYTHMIA EXPERIENCED WAS BRADYCARDIA; NORMAL HEART RATE WAS 72, DURING EVENT IT WAS 39. PREOPERATIVE BP WAS 128/74, BP DURING EVENT WAS 56/27 AT THE LOWEST. THE VNS GENERATOR WAS PROGRAMMED ON FOR THE SURGERY. INTERVENTIONS TAKEN FOR THE INTRAOPERATIVE BRADYCARDIA EVENT WERE DONE TO PRECLUDE A SERIOUS INJURY. THE BRADYCARDIA HAS NOT RECURRED. FOLLOW UP WITH THE REPORTER REVEALED '"PT PRESENTED FOR VENTRAL HERNIA REPAIR ON (B)(6) 2012. PT HAD EVENTFUL PREOPERATIVE COURSE, AND NO ISSUES WITH INDUCTION OF ANESTHESIA. 1 HOUR INTO THE CASE, DURING EXTENSIVE LYSIS OF ADHESIONS IN THE ABDOMEN [USING ELECTROCAUTERY], THE PATIENT BECAME PROFOUNDLY BRADYCARDIC AND HYPOTENSIVE. PT'S ANESTHETIC WAS DECREASED AND HE WAS GIVEN 100% O2, PHENYLEPHRINE 600 MCG TOTAL, GLYCOPYRROLATE 0.1 MG, ATROPINE 0.8 MG, CALCIUM 0.5 MG, MAGNESIUM 1 GM, AND A TOTAL OF 1.7 MG EPINEPHRINE OVER THE COURSE OF ABOUT 30 MINUTES DURING THE SEVERE BRADYCARDIA. A MAGNET WAS ALSO PLACED OVER THE [VNS] DEVICE INTRAOPERATIVELY AND TRANSCUTANEOUS PACING WAS USED DURING THE EVENT. THE CASE WAS ABORTED AND THE PATIENT WAS SUBSEQUENTLY EXTUBATED AND TAKEN TO PACU AND THEN THE ICU FOR OVERNIGHT MONITORING. HE EXPERIENCED NO ABNORMAL SEQUELAE AND RETURNED SEVERAL WEEKS LATER FOR THE PROCEDURE WITHOUT COMPLICATION." IT WAS FELT THE COMBINATION OF THE EXTENSIVE ELECTROCAUTERY USED AND THE VNS STIMULATION MAY HAVE CAUSED THE BRADYCARDIA EVENT PER THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126297 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 014188

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention