BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 4242379 · Received November 11, 2014

    Report

    Report Number
    1644487-2014-02983
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

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

    Description of Event or Problem · 1

    ON (B)(6) 2014 IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE DURING A SYSTEM AND NORMAL MODE DIAGNOSTICS TEST. IT WAS ALSO NOTED THAT THE PATIENT¿S BATTERY IS NEAR END OF SERVICE. THE PATIENT WAS REFERRED FOR A FULL REVISION SURGERY. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2015 IT WAS REPORTED THAT THE PATIENT UNDERWENT A FULL REVISION SURGERY DUE TO HIGH IMPEDANCE AND END OF SERVICE. IT WAS REPORTED THAT THE GENERATOR WAS UNABLE TO BE INTERROGATED DUE TO END OF SERVICE. THE GENERATOR AND LEAD WERE RECEIVED FOR PRODUCT ANALYSIS ON 02/10/2015. PRODUCT ANALYSIS IS UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ON 02/25/2015 PRODUCT ANALYSIS WAS COMPETED ON THE GENERATOR. THE GENERATOR WAS FOUND TO BE AT END OF SERVICE AND WAS DETERMINED TO BE THE RESULT OF NORMAL BATTERY DEPLETION. BASED ON THE ELECTRICAL TEST RESULTS, THE DEVICE EXHIBITED CURRENT CONSUMPTION RATES THAT ARE WITHIN SPECIFICATION, THEREBY DEMONSTRATING NORMAL BATTERY DEPLETION TO AN END-OF-SERVICE CONDITION. A BATTERY LIFE ESTIMATION RESULTED IN 3.00 YEARS REMAINING BEFORE THE ERI FLAG WOULD BE SET. HOWEVER, AN INCOMPLETE PROGRAMMING HISTORY (8.5-YEAR GAP) INDICATES THE ESTIMATION DOES NOT USE ALL THE DATA REQUIRED TO MAKE AN ACCURATE ESTIMATION. THEREFORE, THE ELECTRICAL PERFORMANCE OF THE GENERATOR, AS MEASURED IN THE PRODUCT ANALYSIS LAB, WILL BE USED TO CONCLUDE THAT NO ANOMALIES EXIST AND THE EOS CONDITION IS AN EXPECTED EVENT. THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS; THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE. PRODUCT ANALYSIS ON THE LEAD WAS COMPLETED ON 03/04/2015. WHICH CONFIRMED DISCONTINUITY OF THE POSITIVE QUADFILAR COIL IN THE BODY REGION OF THE RETURNED LEAD PORTIONS; ALSO OBSERVED ABRADED OPENINGS OF THE INNER TUBING NEAR THE BREAK LOCATION. A BREAK WAS IDENTIFIED IN THE POSITIVE COIL AT TWO LOCATIONS. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL END, POSITIVE COIL SEGMENT, AND STRANDS SEGMENTS SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE BREAK LOCATIONS. HOWEVER, DUE TO METAL DISSOLUTION AND/OR SURFACE CONTAMINATION THE FRACTURE MECHANISM CANNOT BE ASCERTAINED. THE INNER SILICONE TUBING OF THE LEAD COILS HAS ABRADED OPENINGS AT THE ENDS. THE LEAD ASSEMBLY HAS DRIED REMNANTS OF WHAT APPEAR TO HAVE ONCE BEEN BODY FLUIDS INSIDE THE INNER AND THE OUTER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED TUBING OPENINGS AND THE END OF THE RETURNED LEAD PORTION. SINCE A PORTION OF THE LEAD (INCLUDING THE UNMARKED CONNECTOR AND THE ELECTRODE ARRAY) WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726857 BIPOL LEAD MODEL 300 LEAD MUZ CYBERONICS, INC. 300-20 739

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR