BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2871771 · Received December 13, 2012

    Report

    Report Number
    1644487-2012-03331
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 20, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    DATE OF EVENT, DESCRIBE EVENT OR PROBLEM; CORRECTED DATA; INADVERTENTLY ENTERED INCORRECT DATE ON INITIAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, DURING PRODUCT ANALYSIS OF THE PATIENT'S EXPLANTED GENERATOR IT WAS DISCOVERED THAT ON (B)(6) 2012, THE IMPEDANCE VALUE INCREASED FROM 13500OHMS TO 21122OHMS. ALTHOUGH THE EXPLANT SURGERY OCCURRED ON (B)(6) 2012, WHICH IS PRIOR TO THIS INCREASE, IT IS UNKNOWN WHETHER THE HIGH IMPEDANCE VALUE OF 13500OHMS WAS OBSERVED PRIOR TO SURGERY OR AFTER SURGERY. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL. THE PATIENT'S PROGRAMMING HISTORY WAS REVIEWED WHICH SHOWED THE LAST SYSTEM DIAGNOSTICS WAS PERFORMED ON (B)(6) 2011, SHOWING LEAD IMPEDANCE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    ALTHOUGH THE EXPLANT SURGERY OCCURRED ON (B)(6) 2012, WHICH IS PRIOR TO THIS INCREASE, IT IS UNKNOWN WHETHER THE HIGH IMPEDANCE VALUE OF 13500 OHMS WAS OBSERVED PRIOR TO SURGERY OR AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200431

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR