BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 2211389 · Received August 15, 2011

    Report

    Report Number
    1644487-2011-01867
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    November 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2011 A VNS IMPLANTING SURGEON'S NURSE REPORTED THAT THE VNS PATIENT WAS HAVING THEIR DEVICE EXPLANTED DUE TO PAINFUL GRANULOMAS AROUND THE LEAD. THE NURSE ALSO REPORTED THAT THE PHYSICIAN DOES NOT BELIEVE THEY ARE RELATED TO VNS BUT IS STILL HAVING THE VNS REMOVED. THE PATIENT PRESENTED DURING A CLINICAL VISIT ABOUT 8-9 MONTHS AGO COMPLAINING OF PAINFUL SCAR TISSUE. DIAGNOSTICS PERFORMED ON THE VNS WERE WITHIN NORMAL LIMITS; SPECIFIC RESULTS NOT PROVIDED. NO REPLACEMENT IS PLANNED AT THIS TIME AS THE PATIENT FEELS IT HAS NOT HELPED HIM. THE PATIENT HAD THEIR GENERATOR EXPLANTED ON (B)(6), 2011. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PATIENT'S PHYSICIAN HAVE BEEN TO NO AVAIL THUS FAR. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 WHEN THE EXPLANTED LEAD AND GENERATOR WERE RETURNED FOR PRODUCT ANALYSIS. THE PHYSICIAN LATER REPORTED ON (B)(6) 2011 THAT THE GRANULOMAS WERE DIRECTLY CAUSED BY THE VNS. THE VNS WAS REMOVED BUT THE WIRE COULD NOT BE FULLY EXTRACTED. THE PATIENT DOES NOT HAVE A MEDICAL HISTORY OF GRANULOMAS PRIOR TO VNS. THE PHYSICIAN REPORTED THAT IT IS UNKNOWN WHAT THE BELIEVED CAUSE FOR THE PATIENT'S LACK OF EFFICACY IS. PRODUCT ANALYSIS OF THE EXPLANTED LEAD PORTION WAS COMPLETED ON (B)(6) 2011. A PORTION OF THE LEAD ASSEMBLY BODY, INCLUDING THE ELECTRODES, WAS NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE RESISTANCE MEASUREMENT TAKEN DURING DECONTAMINATION VERIFIED AN ELECTRICAL AND MECHANICAL CONTACT BETWEEN THE GENERATOR AND CONNECTOR PIN AT ONE POINT IN TIME. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED WITH NO DISCONTINUITIES IDENTIFIED. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS NO EVIDENCE TO SUGGEST AN ANOMALY WITH THE RETURNED PORTION OF THE DEVICE. PRODUCT ANALYSIS ON THE EXPLANTED GENERATOR WAS COMPLETED ON (B)(6) 2011 WHICH REVEALED THAT THE SEPTUM OF THE GENERATOR WAS NOT CORED, THUS ELIMINATING THE POSSIBILITY OF A POTENTIAL UNINTENDED ELECTRICAL CURRENT PATH THROUGH BODY FLUIDS. 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. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD MUZ CYBERONICS, INC. 302-20 1136

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention