BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3081674 · Received April 29, 2013

    Report

    Report Number
    1644487-2013-01051
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 15, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTED TO HAVE INCREASE IN SEIZURES THAT THE PHYSICIAN ATTRIBUTED TO THE BATTERY DEPLETION. THE PHYSICIAN TRIED TO COMMUNICATE WITH THE VNS GENERATOR BUT WAS UNSUCCESSFUL. THIS WAS BELIEVED TO BE DUE TO THE GENERATOR BEING AT END OF SERVICE. THE VNS GENERATOR WAS REPLACED BUT IT WAS REVEALED THAT THE LEAD WAS EXPLANTED AS WELL. A RETURNED PRODUCT FORM INDICATED THE LEAD WAS REPLACED DUE TO A LEAD DISCONTINUITY. IT WAS THEN REVEALED THAT DURING SURGERY THE PHYSICIAN REPLACED THE OLD GENERATOR WITH A NEW ONE, AND WHEN IT WAS CONNECTED TO THE ORIGINAL LEAD HIGH LEAD IMPEDANCE WAS NOTED. AFTER THE LEAD WAS REPLACED DIAGNOSTICS SHOWED GOOD LEAD IMPEDANCE. THE PHYSICIAN ALSO NOTED THAT THE LEAD APPEARED TO BE DAMAGED. NO X-RAYS WERE TAKEN. THE GENERATOR WAS RETURNED TO THE MANUFACTURER ON (B)(4) 2013 BUT THE LEAD WAS NOT RETURNED TO DATE. PRODUCT ANALYSIS WAS PERFORMED ON THE GENERATOR AND THE BATTERY WAS FOUND TO BE DEPLETED. ANALYSIS OF THE GENERATOR IN THE LAB CONCLUDED THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. ATTEMPTS FOR ADDITIONAL INFORMATION AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT HAS BEEN DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183641 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-30 6575

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR