BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2873424 · Received December 14, 2012

    Report

    Report Number
    1644487-2012-03332
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    September 24, 2012
    Report Date
    November 15, 2012
    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
    OH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF THE MANUFACTURING RECORDS FOR THE LEAD CONFIRMED THE LEAD MET ALL FINAL TESTING SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT, CORRECTED DATA: INCORRECT DATE ENTERED IN THIS FIELD ON THE INITIAL MDR. EXPLANT DATE, CORRECTED DATA: EXPLANT DATE INADVERTENTLY NOT INCLUDED IN SUPPLEMENTAL MDR #1. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE NURSE REPORTED THAT HIGH IMPEDANCE WAS FOUND UPON INTERROGATION OF THE PATIENT'S DEVICE THAT DAY. DIAGNOSTICS PERFORMED ON THE LAST VISIT OF (B)(6) 2012 HAD BEEN WITHIN NORMAL LIMITS. THERE WAS NO REPORT OF ANY TRAUMA OR FALL THAT COULD HAVE CAUSED A FRACTURE IN THE LEAD; HOWEVER, X-RAYS WERE TAKEN AND SENT TO THE COMPANY FOR REVIEW. THE PATIENT'S OUTPUT CURRENT WAS NOT DISABLED FOR THE HIGH IMPEDANCE ON THIS VISIT. A REVIEW OF X-RAYS FOUND NO BREAKS OF FRACTURES OF THE LEAD; HOWEVER THERE WERE POTIONS OF THE LEAD THAT COULD NOT BE ASSESSED DUE TO THE IMAGE QUALITY, ANGLE OF THE GENERATOR, AND PORTIONS OF THE LEAD BEING OUTSIDE OF THE IMAGE. FOLLOW UP WITH THE PHYSICIAN FOUND THAT IN ADDITION TO THE HIGH IMPEDANCE, THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES AND THE PATIENT'S MAGNET WAS NO LONGER ABORTING THE SEIZURES. IT WAS ALSO NOTED THAT THE PATIENT IS VERY IMMOBILE, SO THERE IS NO REPETITIVE MOTION FOR HIM. THE FAMILY NOTICED THE INCREASE IN SEIZURES IN THE LAST WEEK OF SEPTEMBER, BUT IT IS UNKNOWN WHAT THE PRE-VNS BASELINE IS SO A COMPARISON OF THE SEIZURE FREQUENCY COULD NOT BE MADE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2013.

    Description of Event or Problem · 1

    A PROGRAMMING HISTORY REVIEW WAS PERFORMED WHICH FOUND THE PATIENT'S LAST SETTINGS FROM (B)(6) 2012 AND SYSTEM DIAGNOSTIC RESULTS FROM DATE OF IMPLANT.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS PERFORMED ON THE EXPLANTED LEAD AND GENERATOR. THE RETURNED PORTION OF THE LEAD MEASURED APPROXIMATELY 41.6CM IN LENGTH. THREE SETS OF SETSCREW MARKS WERE SEEN ON THE CONNECTOR PIN, PROVIDING EVIDENCE THAT PROPER CONTACT BETWEEN THE SETSCREW AND THE LEAD PIN EXISTED AT LEAST ONCE. ALSO, THE CONNECTOR RING HAS SCRATCHES MOST LIKELY CAUSED BY THE CANTED SPRING IN THE PULSE GENERATOR HEADER DURING INSERTION OF THE LEAD CONNECTOR. THE EXACT POINT IN TIME OF WHEN THIS OCCURRED IS UNKNOWN. A DISCOLORED AREA WAS NOTED AT THE END TIP OF THE CONNECTOR PIN. NO OBVIOUS PITTING WAS NOTED AT THIS REGION. THE SMALL O-RING BOOT HAS PARTIAL DETACHMENT FROM THE CONNECTOR RING ASSEMBLY PRIOR TO THE CONNECTOR RING EXPOSED AREA. NO ADVERSE EFFECT WAS IDENTIFIED ON THE DEVICE PERFORMANCE AS A RESULT OF THIS CONDITION. THE CONNECTOR RING HAS WHAT APPEARS TO BE PITTING. SCRATCHES MOST LIKELY CAUSED DURING MANIPULATION OF THE LEAD BY THE USER WERE NOTED ON THE CONNECTOR PIN AND RING. THE LEAD ASSEMBLY IS COVERED WITH WHAT APPEARS TO BE ORGANIC MATTER AT APPROXIMATELY 1CM AND 31-31.6CM FROM BOOT. THE ORGANIC MATTER AS REMOVED TO PERFORM PROPER INSPECTION OF THE LEAD. THE OUTER SILICONE TUBING HAS WHAT APPEAR TO BE INTERNAL ABRASIONS AT MULTIPLE LOCATIONS. AN ABRASION WAS IDENTIFIED ON THE CONNECTOR BOOT. THE OUTER SILICONE TUBING APPEARS TO HAVE BEEN COMPRESSED AT APPROXIMATELY 9, 14.8, AND 17CM FROM BOOT. A KINK IN ONE OF THE LEAD COILS WAS NOTED AT APPROXIMATELY 19.8CM FROM BOOT. THE OUTER SILICONE TUBING HAS CUT OPENINGS AT APPROXIMATELY 26.5CM, 32.6CM, AND 33CM FROM BOOT. THE TUBING CUT AT 32.6CM FROM BOOT REACHED THE INNER SILICONE TUBING OF THE POSITIVE LEAD COIL CREATING AN OPENING. NO OBVIOUS DAMAGE TO THE COIL WAS NOTED AT THIS LOCATION. ABRASION ON THE INNER SILICONE TUBING OF THE LEAD COILS WAS NOTED AT THIS LOCATION. THE LEAD ASSEMBLY HAS REMNANTS OF WHAT APPEARS 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 OPENINGS AND THE ENDS OF THE RETURNED LEAD PORTION. SCANNING ELECTRON MICROSCOPY IMAGES OF THE CONNECTOR RING VERIFIED THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE CONNECTOR RING. NOTE THAT SINCE THE ELECTRODE ARRAY PORTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN THE ABOVE MENTIONED OBSERVATION AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. RESULTS OF DIAGNOSTIC TESTING ON THE GENERATOR INDICATED THAT THE BATTERY STATUS INDICATED IFI=NO IN THE PA LAB. THE BATTERY VOLTAGE WAS 3.024 VOLTS, (NOT AT IFI) AS MEASURED DURING COMPLETION OF TEST PARAMETER 7.16.10.2 OF THE FINAL ELECTRICAL TEST. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 9.631% OF THE BATTERY HAD BEEN CONSUMED. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH CONFIRMED THAT THE SURGERY TOOK PLACE ON (B)(6) 2013. THE EXPLANTED LEAD AND GENERATOR WERE RETURNED ON (B)(6) 2013 AND ARE PENDING PRODUCT ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    REVIEW OF THE MANUFACTURING RECORDS FOR THE LEAD CONFIRMED THE LEAD MET ALL FINAL TESTING SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1283

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention