BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 4233321 · Received November 6, 2014

    Report

    Report Number
    1644487-2014-02957
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER DEVICE HISTORY RECORDS WERE REVIEWED. REVIEW OF THE LEAD DEVICE HISTORY RECORDS CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE HIGH LEAD IMPEDANCE WAS OBSERVED ON SYSTEM DIAGNOSTICS. THE PATIENT REPORTED TO THE PHYSICIAN THAT SEVERAL YEARS AGO HIS VNS HAD A PROBLEM AND WAS TURNED OFF AS A RESULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH LEAD IMPEDANCE WAS DETECTED ON THE PATIENT¿S VNS ON (B)(6) 2014. THE PATIENT REPORTED THAT HE HAD HIS DEVICE PROGRAMMED OFF SEVERAL YEARS AGO. UPON INTERROGATION, THE DEVICE WAS STILL ON. HOWEVER DUE TO THE OBSERVANCE OF HIGH IMPEDANCE, THE DEVICE WAS THEN PROGRAMMED OFF. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712872 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 4758

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR