BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 2820787 · Received November 6, 2012

    Report

    Report Number
    1644487-2012-02901
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 9, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT'S LEFT VOCAL CORD WAS PARALYZED AS A RESULT OF THE VNS IMPLANT SURGERY. THE VNS IS CURRENTLY ACTIVATED AND THE PATIENT IS DOING WELL. THE PATIENT'S VOICE IS REPORTED AS "NORMAL." THERE WERE NOT ANY INTERVENTIONS DONE FOR THE VOCAL CORD PARALYSIS OTHER THAN LETTING THE PATIENT RECOVER FROM HER SURGERY.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT'S VOICE HAS "RETURNED TO NORMAL" AND THE VOCAL CORD PARALYSIS WAS FELT TO BE DUE TO THE VNS REVISION SURGERY WHICH OCCURRED ON (B)(6) 2012.IT HAS NOT BEEN CONFIRMED IF THE VNS HAS BEEN ACTIVATED.ATTEMPTS FOR ADDITIONAL INFORMATION ARE STILL IN PROGRESS.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT DEVELOPED VOCAL CORD PARALYSIS FOLLOWING VNS LEAD AND GENERATOR REPLACEMENT SURGERY ON (B)(6) 2012. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 304 LEAD LYJ CYBERONICS INC 304-20 202107

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention