BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 4102898 · Received September 19, 2014

    Report

    Report Number
    1644487-2014-02400
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    April 24, 2001
    Report Date
    August 26, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OPERATIVE NOTES FROM EXPLANT SURGERY ON (B)(6) 2014 WERE RECEIVED AND INDICATED THAT THE PRE- AND POST-OPERATIVE DIAGNOSES WAS DYSPNEA AND CHRONIC LARYNGITIS. THE INDICATION FOR PROCEDURE DETAILED THAT THE PATIENT DEVELOPED CHRONIC LARYNGITIS WITH SYMPTOMS OF CONSTRICTION OF THE LARYNX AFTER VNS IMPLANT, WHICH MAY BE RELATED TO THE VAGAL NERVE STIMULATOR LEAD. THE SURGEON NOTED THAT THEY HAD CONCERNS THAT THE VAGAL NERVE STIMULATOR MAY BE ¿INAPPROPRIATELY ACTIVATING THE RECURRENT LARYNGEAL NERVE. BECAUSE OF THIS, THE DEVICE WILL NEED TO BE REMOVED." THE GENERATOR (INCLUDING SURROUNDING SCAR TISSUE) AND MAJORITY OF LEAD WERE EXPLANTED; ALL OF THE ELECTRODES WERE NOT EXPLANTED, ¿RECOGNIZING THE RISK OF ADDITIONAL DISSECTION WAS CERTAINLY NOT WARRANTED BY ANY BENEFIT OF HARVESTING ADDITIONAL NERVE LEAD WIRE.¿

    Description of Event or Problem · 1

    THE PATIENT HAD GENERATOR AND LEAD EXPLANT SURGERY ON (B)(6) 2014 TO UNDERGO OTHER INDICATION TREATMENT. THE EXPLANTED PRODUCTS WERE DISCARDED.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2014 REPORTED THAT BY THE PATIENT¿S REPORT, SHE HAD OCCASIONS OF UNILATERAL VOCAL CORD PARALYSIS FOLLOWING VNS PROCEDURE. SUBSEQUENTLY, SHE SEEMED TO STABILIZED AFTER UNDERGOING A VOCAL FOLD INJECTION PROCEDURE. THE VOCAL FOLDS WERE EVALUATED TO BE BILATERALLY MOBILE WITH EXHIBITION OF MILD EDEMA. THE PATIENT PRESENTED WITH REPORT OF PROGRESSIVELY WORSENING BREATHING DIFFICULTIES. THE VNS GENERATOR WAS PROGRAMMED OFF TO 0MA WHICH THE PHYSICIAN EVALUATED MAY PROVIDE SOME IMMEDIATE RELIEF WITH RESPECT TO THE BREATHING ISSUES. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD VNS PROGRAMMING CHANGES MADE DUE TO TOLERABILITY ISSUES INCLUDING WITH SUBTLE HOARSENESS DURING STIMULATION BUT WAS TOLERATED. A NOTE FROM (B)(6) 2007 INDICATED THE PATIENT HAD INCREASING BREATHING PROBLEMS AND WAS UNKNOWN IF RELATED TO A RECENT INCREASE IN SETTINGS. LATER IN (B)(6) 2008, THE PATIENT FELT THE BREATHING ISSUES WERE RELATED TO VNS AND AS A RESULT DID NOT WANT TO INCREASED SETTINGS. IN (B)(6) 2008, THE TREATING PHYSICIAN INDICATED THE PATIENT¿S ASTHMA WAS WORSE AND UNKNOWN IF RELATED TO VNS AT THAT TIME. THE PATIENT'S PREVIOUSLY TREATING PHYSICIAN WHO MANAGED THE VNS TREATMENT HAS RETIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584564 BIPOL LEAD MODEL 300 LEAD MUZ CYBERONICS, INC. 300-20 737

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention