BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 3153582 · Received June 8, 2013

    Report

    Report Number
    1644487-2013-01707
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    August 15, 2011
    Report Date
    May 10, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT HAVE X-RAYS DONE. THERE WAS NOT ANY MANIPULATION OR TRAUMA THAT WAS NOTED THAT WOULD HAVE CONTRIBUTED TO THE HIGH IMPEDANCE. PRODUCT RETURN ATTEMPTS ARE IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A PATIENT HAD A LEAD AND GENERATOR REPLACEMENT BACK IN 2011. UPON REVIEW OF PROGRAMMING HISTORY IT WAS SHOWN THAT THE PATIENT HAD HIGH IMPEDANCE. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED PRODUCTS WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SITE DISCARDS GENERATORS WHICH ARE AT END OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259146 LEAD MODEL UNK LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR