BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2801815 · Received October 23, 2012

    Report

    Report Number
    1644487-2012-02702
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    June 19, 2012
    Report Date
    September 25, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DATE OF EVENT, CORRECTED DATA: PER REVIEW OF THE GENERATOR'S INTERNAL DATA, THE HIGH IMPEDANCE EVENT OCCURRED ON (B)(6) 2012. ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT HAD VNS LEAD AND GENERATOR REPLACEMENT SURGERY PERFORMED ON (B)(6) 2013. THE EXPLANTED GENERATOR AND LEAD REMNANT WERE RETURNED FOR ANALYSIS ON (B)(6) 2013. ANALYSIS OF THE GENERATOR DID NOT NOTE ANY ANOMALIES, AND THE GENERATOR PERFORMED PER SPECIFICATIONS. REVIEW OF THE GENERATOR'S INTERNAL DATA NOTED AN IMPEDANCE CHANGE OCCURRED ON (B)(6) 2012 FROM 2309 OHMS (NORMAL IMPEDANCE) TO 12255 OHMS (HIGH IMPEDANCE). THE HIGH LEAD IMPEDANCE LIKELY OCCURRED INITIALLY ON (B)(6) 2012. ANALYSIS OF THE LEAD REMNANT DID NOT IDENTIFY ANY ANOMALIES OTHER THAN TYPICAL EXPLANT-RELATED OBSERVATIONS. HOWEVER, ONLY THE LEAD PIN AND A VERY SMALL PORTION OF THE LEAD BODY (1.9CM) WAS RETURNED FOR ANALYSIS. BASED ON THE LOCATION OF THE SETSCREW MARKS THE LEAD PIN WAS ADEQUATELY INSERTED, RULING OUT A LEAD PIN ISSUE AND MAKING A LEAD FRACTURE MORE LIKELY.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT HAD HIGH LEAD IMPEDANCE WITH VNS DIAGNOSTICS TESTING. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    REPORTER INDICATED THE VNS WAS DISABLED ON (B)(6) 2012. A FRANK BREAK WAS SEEN VIA X-RAY IN THE VNS LEAD ELECTRODE AREA PER THE REPORTER. THE PATIENT HAD NO TRAUMA PER THE MOTHER, AND DOES NOT MANIPULATE THE VNS. THE LAST GOOD VNS DIAGNOSTICS RESULTS WERE ON (B)(6) 2012, BUT WERE NOT SPECIFIED. A SURGERY DECISION REGARDING THE VNS HAS NOT BEEN MADE YET PER THE MOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 201233

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR