BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1872509 · Received October 12, 2010

    Report

    Report Number
    1644487-2010-02282
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 13, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MFR REVIEW X-RAYS OF IMPLANTED DEVICE. RESULTS: X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED. CONCLUSIONS: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED BY THE NURSE, THAT WHEN THE VNS PT WAS SEEN FOR A ROUTINE F/U APPOINTMENT, AND WHEN A SYSTEM DIAGNOSTIC TEST WAS PERFORMED, THE RESULTS REVEALED HIGH LEAD IMPEDANCE, LEAD IMPEDANCE >=10,000 OHMS. THE DEVICE WAS PROGRAMMED OFF AS INTERVENTION. THERE WERE NO REPORTS OF TRAUMA TO THE PT. THE NURSE STATED THAT THE PT'S SEIZURES HAVE IMPROVED RECENTLY; THIS MAY BE DUE TO VNS OR CHANGE IN MEDICATION. THE DEVICE HAS BEEN TURNED OFF AND THERE HAS NOT BEEN ANY REPORT OF SEIZURE ACTIVITY. X-RAYS WERE TAKEN AND ASSESSED. THERE WERE NO OBVIOUS LEAD DISCONTINUITIES OBSERVED. THE FOLLOWING OBSERVATIONS WERE MADE DURING THE X-RAY REVIEW BY THE MFR; THERE WAS A SUSPECT AREA OF THE LEAD BODY NEAR THE GENERATOR WHERE A LEAD DISCONTINUITY WAS NOT ABLE TO BE RULED OUT, AND THERE WAS A SHARP ANGLE IN THE LEAD, CAUDAL TO THE ANCHOR TETHER LOCATION, PRIOR TO FORMATION OF THE STRAIN RELIEF BEND. THE PT WILL LIKELY BE REFERRED TO A SURGEON TO FURTHER EXPLORE THE CAUSE OF THE HIGH LEAD IMPEDANCE.

    Description of Event or Problem · 1

    CONFIRMATION WAS MADE THROUGH THE AREA REPRESENTATIVE INDICATING THE PATIENT UNDERWENT REPLACEMENT SURGERY AS SCHEDULED. THE EXPLANTED LEAD WAS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED GENERATOR AND LEAD WAS COMPLETED BY THE MANUFACTURER. ANALYSIS OF THE RETURNED GENERATOR INDICATED THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. ANALYSIS OF THE RETURNED LEAD INDICATED THE CONDITION OF THE RETURNED LEAD PORTIONS WAS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, WITH NO DISCONTINUITIES IDENTIFIED. NOTE THAT SINCE A LARGE PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THROUGH THE AREA REPRESENTATIVE INDICATING THAT THE PATIENT WOULD UNDERGO LEAD REPLACEMENT SURGERY DUE TO HIGH LEAD IMPEDANCE. AT THE MOMENT CONFIRMATION OF SURGICAL INTERVENTION HAS NOT BEEN MADE AS (B)(4) ATTEMPTS REMAIN UNDERWAY.

    Description of Event or Problem · 1

    THE PATIENT'S EXPLANTED LEAD AND GENERATOR WERE RETURNED FOR ANALYSIS. ANALYSIS COMPLETION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 6901

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR