BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3202994 · Received July 2, 2013

    Report

    Report Number
    1644487-2013-02022
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES; CORRECTED DATA: MFR. REPORT #02 INADVERTENTLY LISTED THE WRONG EVALUATION CODES FOR THE SUSPECT DEVICE. THE LEAD BREAK NOTED IN MFR. REPORT #02 WILL NOW BE HOUSED IN MFR. REPORT # 1644487-2014-00768.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED.REVIEW OF MANUFACTURING RECORDS CONFIRMED THE DEVICE MET ALL FINAL TESTING SPECIFICATIONS AND STERILIZATION STANDARDS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    A LETTER DATED (B)(6) 2013 WAS RECEIVED FROM THE PHYSICIAN WITH A SUMMARY OF THE INFECTION EVENT. THE LETTER STATES THAT THE PATIENT PRESENTED THREE WEEKS AFTER SURGERY (PERFORMED ON (B)(6) 2013) WITH AN OBVIOUS CELLULITIS OF THE GENERATOR POCKET. THE PHYSICIAN ATTEMPTED TO MANAGE THIS WITH ASPIRATION, IRRIGATION AND TREATMENT WITH ANTIBIOTICS. THE CULTURES THAT WERE OBTAINED SHOWED (B)(6) THAT WAS SENSITIVE TO ANTIBIOTICS, EXCEPT TETRACYCLINE. THE PATIENT WAS TREATED FOR 40 DAYS WITH KEFLEX AND, IN SPITE OF THESE MEASURES, THE PHYSICIANS WERE NOT ABLE TO GET THE INFECTION CLEARED AND THE INCISION DEHISCED (B)(6) 2013. THIS NECESSITATED REMOVAL OF THE GENERATOR AND THE PATIENT'S WOUND HAS SUBSEQUENTLY HEALED WELL. THE ELECTRODE ARRAY WAS REMOVED AT THE TIME OF THE GENERATOR REMOVAL ON (B)(6) 2013. THE PATIENT HAS RECOVERED UNEVENTFULLY FROM THE SURGERY. IT IS NOT BELIEVED THERE WAS ANY MANIPULATION OR TRAUMA OF THE GENERATOR THAT CAUSED THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE PHYSICIAN FOUND THAT THE PATIENT'S SEIZURE FREQUENCY DID NOT IMPROVE FOLLOWING THE GENERATOR REPLACEMENT ON (B)(6) 2013 HOWEVER THE PATIENT DEVELOPED AN INFECTION AT THE SITE THAT DID NOT RESPOND TO IV ANTIBIOTICS AND THE VNS GENERATOR AND LEADS WERE SUBSEQUENTLY REMOVED. PRODUCT ANALYSIS OF THE EXPLANTED GENERATOR FOUND THAT THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS OF THE CURRENT AUTOMATED FINAL TEST. ANALYSIS IN 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. PRODUCT ANALYSIS OF THE EXPLANTED LEAD WAS PERFORMED. ABRADED OPENINGS WERE NOTED AT THE LEAD BODY IN THE OUTER TUBING AND THE INNER SILICONE OF THE POSITIVE COIL TUBING. ALSO, A SUSPECTED COIL BREAK WAS IDENTIFIED AT THE END OF THE POSITIVE COIL OF THE RETURNED LEAD PORTION. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL END SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE END OF THE POSITIVE COIL. THE EXACT REASON FOR THIS CONDITION IS UNKNOWN. DUE TO METAL DISSOLUTION THE FRACTURE MECHANISM CANNOT BE DETERMINED. 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. INCISIONS IN THE SILICONE TUBING WERE NECESSARY TO PERFORM PROPER INSPECTION OF THE LEAD COILS. 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

    IT WAS REPORTED THAT THE PATIENT'S GENERATOR AND LEAD WERE EXPLANTED ON (B)(6), 2013 DUE TO AN INFECTION. AN ATTEMPT HAS BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, IT WAS UNSUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE EXPLANTED DEVICES WERE RETURNED ON (B)(6), 2013 AND ARE PENDING PRODUCT ANALYSIS. A REPLACEMENT VNS DEVICE WAS NOT IMPLANTED AT THE TIME OF SURGERY. REVIEW OF THE MANUFACTURING RECORDS FOR THE GENERATOR AND LEAD CONFIRMED THAT BOTH THE LEAD AND GENERATOR PASSED ALL FINAL SPECIFICATION TESTING AND STERILIZATION STANDARDS PRIOR TO DISTRIBUTION. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301010 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 202430

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other