BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3913659 · Received July 3, 2014

    Report

    Report Number
    1644487-2014-01699
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    May 3, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS OF THE LEAD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. 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 LEAD BREAKS. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING GENERATOR REPLACEMENT FOR END OF SERVICE THE LEAD WAS FOUND WRAPPED/COILED AROUND THE GENERATOR AND WAS FRAYED. THE SURGEON DID NOT WANT TO REPLACE THE LEAD AT THIS TIME DUE TO THE SCAR TISSUE AND NEVER HAVING PERFORMED THIS OPERATION BEFORE. THE SURGEON BELIEVED THAT THE SCAR TISSUE WAS FROM THE INITIAL VNS IMPLANT. THE EXPLANTED LEAD AND GENERATOR HAVE NOT BEEN RECEIVED FOR ANALYSIS TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. BASED ON THE ELECTRICAL TEST RESULTS, THE GENERATOR EXHIBITED CURRENT CONSUMPTION RATES THAT ARE WITHIN SPECIFICATION, THEREBY DEMONSTRATING NORMAL BATTERY DEPLETION TO A NEAR-END-OF-SERVICE (NEOS) CONDITION. A BATTERY LIFE ESTIMATION RESULTED IN 1.00 YEARS REMAINING BEFORE THE NEAR-END-OF-SERVICE (NEOS) FLAG WOULD BE SET. HOWEVER, AN INCOMPLETE PROGRAMMING/DIAGNOSTICS HISTORY (4.5-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 PA LAB, WILL BE USED TO CONCLUDE THAT NO ANOMALIES EXIST AND THE NEAR-END-OF-SERVICE (NEOS) CONDITION IS AN EXPECTED EVENT. THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. ABRADED OPENINGS WERE NOTED IN THE OUTER AND THE INNER SILICONE TUBING OF THE LEAD COILS RESULTING IN PORTIONS OF THE LEAD COILS BEING EXPOSED AND FLUID BEING FOUND IN THE INNER AND OUTER TUBING. ALSO, THE LEAD COILS HAVE WEAR (FLAT SURFACES) AT THE LEAD BODY. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE AREA WHERE THE WEAR (FLAT SURFACES) WAS NOTED. SCANNING ELECTRON MICROSCOPY IMAGE OF THE NEGATIVE COIL SHOW THAT WEAR (FLAT SURFACES) OCCURRED IN THE VICINITY OF THE LOOP. 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 OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS NO A ¿TWIDDLER:¿ THE SURGEON WAS NOT COMFORTABLE PERFORMING A COMPLETE REVISION AND JUST EXPLANTED THE GENERATOR AND PART OF THE LEAD THAT IS BEING RETURNED. THE GENERATOR AND LEAD WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391476 LEAD MODEL 302 LEAD LYJ LIVANOVA USA, INC. 302-20 1354

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male NA.