BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3170202 · Received June 14, 2013

    Report

    Report Number
    1644487-2013-01786
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 22, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT HAD A PROPHYLACTIC GENERATOR REPLACEMENT ON (B)(6) 2013. THE PATIENT REPORTED PAINFUL STIMULATION WAS OCCURRING PRIOR TO THE REPLACEMENT. THE OLD GENERATOR WAS INTERROGATED PRIOR TO REMOVAL AND LEAD IMPEDANCE WAS OK, WITH A DCDC OF 0. THE NEW GENERATOR WAS IMPLANTED AND LEAD IMPEDANCE WAS ¿OK¿ WITH A READING OF 1500 OHMS. DURING REPLACEMENT, THE CURRENT LEAD WAS OBSERVED BY SURGEON TO HAVE FLUID INSIDE IT. X-RAYS WERE PERFORMED PRIOR TO SURGERY AND NO LEAD BREAK WAS OBSERVED. THE PATIENT WAS PROGRAMMED TO PRIOR SETTINGS PER SURGEON. IT WAS LATER REPORTED THAT THERE IS AN ISSUE WITH THE LEAD SO THE PATIENT¿S LEAD WILL ALSO BE REPLACED. THE PATIENT UNDERWENT A FULL REVISION SURGERY ON (B)(6) 2013. DEVICE DIAGNOSTICS AND LEAD IMPEDANCE WERE ¿OK¿. IT WAS STATED THAT THE PAINFUL STIMULATION OCCURRED IN THE LEFT CHEST AND THE FULL REVISION SURGERY ON JUNE 10, 2013 WAS INTERVENTION FOR THE PAINFUL STIMULATION. ATTEMPTS WERE MADE FOR THE RETURN OF THE EXPLANTED PRODUCTS BUT THEY HAVE NOT BEEN RECEIVED TO DATE. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE PHYSICIAN DESPITE REQUEST FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE GENERATOR THAT WAS PROPHYLACTICALLY EXPLANTED ON (B)(6), 2013 WAS RETURNED FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR AND LEAD WHICH WERE EXPLANTED (B)(6) 2013 TO A LEAD DISCONTINUITY AND PAINFUL STIMULATION. RESULTS OF DIAGNOSTIC TESTING INDICATED THAT THE BATTERY STATUS INDICATED IFI=NO IN THE PA LAB. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. AN ABRADED OPENING WAS IDENTIFIED IN THE OUTER SILICONE TUBING AT THE LEAD BODY. THE LEAD ASSEMBLY HAS REMNANTS OF WHAT APPEAR TO BE DRY BODY FLUIDS INSIDE THE INNER AND THE OUTER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED TUBING OPENING AND THE CUT END OF THE RETURNED LEAD PORTION. NOTE THAT SINCE A PORTION OF THE LEAD (INCLUDING THE ELECTRODE ARRAY) 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.

    Description of Event or Problem · 1

    ON (B)(4) 2013 THE LEAD AND GENERATOR THAT WERE EXPLANTED ON (B)(6) 2013 DUE TO A LEAD DISCONTINUITY AND PAINFUL STIMULATION WERE RETURNED FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS ON THESE IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED. ON (B)(4) 2013 PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR THAT WAS EXPLANTED ON (B)(6) 2013. IN THE PRODUCT ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND THE PRODUCT ANALYSIS LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270676 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-30 4919

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other