BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 4132917 · Received October 1, 2014

    Report

    Report Number
    1644487-2014-02529
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION, CORRECTED DATA: FOLLOW-UP REPORT #1 INADVERTENTLY DID NOT INCLUDE PATIENT'S DIFFICULTY SPEAKING DURING CLINIC VISIT ON (B)(6) 2014.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT FULL REVISION OF THE GENERATOR AND LEAD ON (B)(6) 2015. THE EXPLANTED PRODUCTS WERE REPORTED TO BE DISCARDED AND COULD NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    FOLLOW-UP REPORT #1 INADVERTENTLY DID NOT INCLUDE THAT THE PATIENT ALSO EXPERIENCED DIFFICULTY SPEAKING DURING CLINIC VISIT ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DURING AN OFFICE VISIT ON (B)(6) 2014, THE VNS PATIENT COMPLAINED OF HAVING SHOCKING SENSATIONS IN HER NECK ALONG WITH DYSPHAGIA AND MUSCLE SPASMS. THE PATIENT HAD TEMPORARILY DISABLED HER DEVICE WITH HER MAGNET AND THE PHYSICIAN PROGRAMMED THE DEVICE OFF DURING THE OFFICE VISIT. DURING AN OFFICE VISIT ON (B)(6) 2014, THE PATIENT¿S DEVICE WAS PROGRAMMED BACK ON AND THE PATIENT SUBSEQUENTLY HAD A NOSE BLEED AND COUGHING WITH STIMULATION. THE PATIENT¿S DEVICE WAS TESTED AND SHOWED NORMAL DEVICE FUNCTION AT THE TIME. THE PATIENT¿S DEVICE WAS AGAIN DISABLED FOR COMFORT. NO PATIENT TRAUMA OR PROGRAMMING CHANGES PRECEDED THE ONSET OF THE PATIENT¿S ISSUES. THE PATIENT WAS REFERRED FOR SURGERY BUT NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS EXPERIENCING PAINFUL STIMULATION. THE PATIENT¿S DEVICE WAS SUBSEQUENTLY DISABLED AND THE PATIENT WAS REFERRED FOR SURGERY. THE PATIENT¿S PHYSICIAN WAS SUSPECTING A POTENTIAL ISSUE WITH THE LEAD. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613273 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 2639

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention