BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2981630 · Received February 27, 2013

    Report

    Report Number
    1644487-2013-00541
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED MDR OMITTED CONCLUSION TO INDICATE THAT THE DEVICE WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THIS VNS PATIENT HAD HIGH IMPEDANCE AND WAS REFERRED FOR REVISION SURGERY. CLINIC NOTES DATED (B)(6) 2013 STATED THAT HIGH IMPEDANCE WAS SEEN AND THAT LEAD REVISION WAS NEEDED. THE PATIENT'S SEIZURES HAD NEVER BEEN COMPLETELY CONTROLLED. THE PATIENT WAS REPORTEDLY SWIPING HIS MAGNET MORN AND NIGHT. THE PATIENT'S LAST SEIZURE WAS ONCE WEEK PRIOR AND DID NOT RESPOND TO THE MAGNET. THE PATIENT COULD NOT FEEL THE VNS GO OFF WITH OR WITHOUT THE MAGNET. HIGH IMPEDANCE WAS FIRST SEEN ON 01/18/2012. PREVIOUS DIAGNOSTICS WERE FROM (B)(6) 2012 AND INDICATED NORMAL IMPEDANCE. IT WAS LATER REPORTED THAT THE PATIENT'S MAGNET WAS NOT WORKING TO ABORT SEIZURES. THE PATIENT HAD TWO EPISODES THAT MORNING AND OBTAINED A MOUTH INJURY IN THE PROCESS. THE PATIENT SUGGESTED HE MIGHT NEED TO GO TO THE ER, BUT THE PHYSICIAN WAS UNCERTAIN ABOUT THE EVENTS. THE PATIENT UNDERWENT FULL REVISIONS ON (B)(6) 2103. THE EXPLANTED PRODUCTS WERE DISCARDED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS SEEN ON (B)(6) 2013. THE PATIENT REPORTED THAT HE NO LONGER FELT MAGNET STIMULATION. THE PATIENT HAD ALSO EXPERIENCED 3 SEIZURES IN THE LAST TWO MONTHS WHICH WAS AN INCREASE IN SEIZURES (BELOW HIS PRE-VNS BASELINE). DIAGNOSTICS WERE RUN, AND HIGH IMPEDANCE WAS RETURNED. NO X-RAYS WERE TAKEN, AND THE PATIENT WAS REFERRED FOR REVISION. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84019 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 7416

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR