BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2833268 · Received November 15, 2012

    Report

    Report Number
    1644487-2012-03015
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 22, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED A GROSS LEAD DISCONTINUITY. DEVICE FAILURE OCCURRED, 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.

    Description of Event or Problem · 1

    REPORTER INDICATED VNS LEAD AND GENERATOR REPLACEMENT SURGERY OCCURRED ON (B)(6) 2012. THE EXPLANTED LEAD AND GENERATOR HAVE BEEN RETURNED AND ARE PENDING ANALYSIS.

    Description of Event or Problem · 1

    GENERATOR PA WAS APPROVED ON (B)(4) 2013. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. THE LEAD ASSEMBLY WAS RETURNED FOR ANALYSIS DUE TO THE FOLLOWING HIGH IMPEDANCE. THE HIGH IMPEDANCE WAS VERIFIED AS INDICATED BY A BREAK IDENTIFIED IN THE POSITIVE AND NEGATIVE LEAD COILS. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED ON THE COIL. DUE TO METAL DISSOLUTION THE FRACTURE MECHANISM OF THE POSITIVE COIL CANNOT BE DETERMINED. SCANNING ELECTRON MICROSCOPY IMAGES OF THE NEGATIVE COIL SHOW APPEARANCE SUGGESTING THAT, A STRESS-INDUCED FRACTURE HAS OCCURRED IN AT LEAST TWO OF THE STRANDS OF THE NEGATIVE QUADFILAR COIL. HOWEVER, DUE TO MECHANICAL DISTORTION THE FRACTURE MECHANISM OF OTHER STRANDS CANNOT BE DETERMINED. SCANNING ELECTRON MICROSCOPY IMAGES OF THE LEAD COILS AT A SECOND PORTION OF THE LEAD, SHOW APPEARANCE SUGGESTING THAT A STRESS-INDUCED FRACTURE HAS OCCURRED IN AT LEAST TWO STRANDS OF EACH QUADFILAR COIL. HOWEVER, DUE TO MECHANICAL DISTORTION (SMOOTHED SURFACES AND/OR SURFACE CONTAMINATION A CONCLUSIVE DETERMINATION OF THE FRACTURE MECHANISM ON THE OTHER STRANDS CANNOT BE DETERMINED. ALSO, THE NEGATIVE COIL HAS WHAT APPEAR TO BE VOIDS IN ONE STRAND AT THE VICINITY OF ONE BROKEN STRAND. NOTE THAT SINCE A PORTION OF THE LEAD WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. PROGRAMMING HISTORY SHOWS THAT THE DEVICE WAS PROGRAMMED OFF ON (B)(6) 2012.

    Description of Event or Problem · 1

    X-RAYS OF THE PATIENT'S VNS DEVICE WERE REVIEWED BY THE MANUFACTURER ON (B)(4) 2012. THE GENERATOR FILTER FEED-THROUGH WIRES APPEAR TO BE INTACT, AND THE LEAD CONNECTOR PINS APPEAR TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. ONE LEAD BREAK WAS FOUND APPROXIMATELY IN THE MIDDLE OF THE LEAD BODY. A SUBSTANTIAL SECTION OF THE LEAD IS WOUND IN SMALL LOOPS CLOSE TO THE GENERATOR, POINTING TO THE POSSIBILITY OF MANIPULATION OF THE GENERATOR (TWIDDLER). BASED ON THE X-RAYS IMAGES, THE LEAD BREAK IS EXPECTED TO BE RESPONSIBLE FOR THE HIGH IMPEDANCE REPORTED.

    Description of Event or Problem · 1

    REPORTER INDICATED HIGH LEAD IMPEDANCE WAS NOTED WITH VNS DIAGNOSTICS TESTING AT A PATIENT'S OFFICE VISIT. X-RAYS SHOWED A CLEAR LEAD BREAK AT THE PROTHORACAL GRADIENT OVER THE 3RD LEFT RIB, THIS OVER A LENGTH OF 2.5 CM, WITH EVIDENCE OF "TWIDDLING" THE LEAD. PER THE PATIENT'S PARENTS, THE PATIENT DOES TOUCH OR GRAB AT THE GENERATOR, BUT DIRECT MANIPULATION HAS NOT BEEN SEEN. THE PATIENT DOES FALL REGULARLY. SURGERY TO REPLACE THE VNS GENERATOR AND LEAD IS LIKELY, BUT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 5423

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR