BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3050593 · Received April 10, 2013

    Report

    Report Number
    1644487-2013-00975
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    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
    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

    ANALYSIS OF THE VNS GENERATOR WAS COMPLETED. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT DURING PROPHYLACTIC VNS GENERATOR REPLACEMENT, LOW LEAD IMPEDANCE READINGS WERE OBTAINED WITH THE RESIDENT LEAD AND NEW GENERATOR. A SHORT CIRCUIT OF THE LEAD WAS SUSPECTED DUE TO THE LOW IMPEDANCE, AND A NEW LEAD WAS IMPLANTED WITH THE NEW GENERATOR. X-RAYS WERE NOT DONE PRIOR TO THE SURGERY, AND THE PATIENT HAD NO KNOWN TRAUMA AND DID NOT MANIPULATE THE VNS. REVIEW OF AVAILABLE IN-HOUSE PROGRAMMING HISTORY DID NOT NOTE ANY LOW IMPEDANCE IN THE DIAGNOSTICS HISTORY. ATTEMPTS FOR RETURN OF THE EXPLANTED DEVICES ARE IN PROGRESS.

    Description of Event or Problem · 1

    ATTEMPTS FOR RETURN OF THE EXPLANTED VNS LEAD HAVE BEEN UNSUCCESSFUL TO DATE. THE EXPLANTED VNS GENERATOR WAS RETURNED ON (B)(6) 2013 AND IS PENDING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152654 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 1169

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR