BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3023497 · Received March 27, 2013

    Report

    Report Number
    1644487-2013-00834
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT HAS A PACEMAKER IMPLANTED. THE IMPLANT DATE OR THE RELATIONSHIP OF THEIR CARDIAC EVENT TO THEIR VNS DEVICE IS NOT KNOWN AT THIS TIME. THE PATIENT'S PHYSICIAN WHO WAS FOLLOWING THE PATIENT AT THE TIME HAS PASSED AWAY. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS ABOUT THIS EVENT. THE PATIENT DOES NOT CURRENTLY HAVE A TREATING VNS PHYSICIAN.

    Description of Event or Problem · 1

    NO INTERVENTIONS ARE PLANNED FOR THE PATIENT AT THIS TIME. THEY WILL BE MONITORED FOR A WHILE AND FOLLOWED WITH A NEW NEUROLOGY TEAM. NO FURTHER INFORMATION HAS BEEN RECEIVED IN REGARDS TO THEIR PACEMAKER AND THEIR VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126409 PULSE GEN MODEL 102R PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 014865

    Patients

    Seq Age Sex Outcome Treatment
    1 Other