BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 3121548 · Received May 21, 2013

    Report

    Report Number
    1644487-2013-01479
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    February 21, 2013
    Report Date
    April 29, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A FULL REVISION SURGERY DUE TO A RIGHT SIDE INFECTION IN THE PAST. NO FURTHER INFORMATION WAS PROVIDED. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE TO THE PHYSICIAN BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT UNDERWENT A FULL REVISION SURGERY ON (B)(6) 2013. ¿OTHER¿ WAS MARKED AS THE REASON FOR REPLACEMENT AND A HANDWRITTEN REASON WAS GIVEN BUT THE HANDWRITING WAS ILLEGIBLE. THE LEAD IMPEDANCE AFTER SURGERY WAS NOTED TO BE ¿OK¿. CLARIFICATION ON WHAT THE REASON FOR THE FULL REVISION SURGERY WAS HAS BEEN REQUESTED BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224798 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR