BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 3121533 · Received May 21, 2013

    Report

    Report Number
    1644487-2013-01478
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 29, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Description of Event or Problem · 1

    THE EXPLANTED LEAD AND GENERATOR WERE NOT RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS DESPITE ATTEMPTS FOR THEIR RETURN.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE VNS PATIENT¿S GENERATOR WAS AT EOS AND WAS REFERRED FOR A BATTERY REPLACEMENT. IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2013 BUT THE SURGEON DID NOT CHANGE THE BATTERY DUE TO SCAR TISSUE. NO ELABORATION WAS GIVEN. IT WAS ALSO STATED THAT THE GENERATOR WAS NOT REPLACED BECAUSE THE ¿LEADS WERE NOT FUNCTIONING¿. IT WAS LATER REPORTED THAT THE PATIENT¿S GENERATOR AND LEAD HAD INDEED BEEN REPLACED ON (B)(6) 2013; IT WAS BELIEVED THAT HIGH IMPEDANCE HAD BEEN OBSERVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN BUT HAS NOT BEEN RECEIVED TO DATE. THE PATIENT¿S LEAD PRODUCT INFORMATION HAS BEEN REQUESTED FROM THE IMPLANTING HOSPITAL BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224750 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other