BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2862854 · Received December 10, 2012

    Report

    Report Number
    1644487-2012-03251
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 9, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE HIS VNS REMOVED. CLINIC NOTES DATED (B)(6) 2012, INDICATED THAT THE PATIENT WAS EXPERIENCING PAIN ON THE LEFT SIDE OF HIS CHEST AND NUMBNESS AT HIS INCISION SITE. ADDITIONALLY IT WAS INDICATED THAT THE PATIENT WAS NEVER DOING "WELL" UNTIL THE GENERATOR WAS TURNED OFF. SINCE THAT TIME HE HAS NOT HAD ANY MORE SEIZURES. THE PATIENT WAS REFERRED FOR GENERATOR EXPLANT DUE TO THE PAIN. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2012 THAT THE PATIENT HAD HIS GENERATOR AND LEAD EXPLANTED ON (B)(6) 2012. THE PATIENT WAS NOT RE-IMPLANTED. THE EXPLANTED PRODUCTS WERE RETURNED TO THE MANUFACTURER ON (B)(4) 2012 AND PRODUCT ANALYSIS IS CURRENTLY IN PROGRESS AND HAS NOT BEEN COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS ON THE GENERATOR WAS COMPLETED ON (B)(6) 2013. IN THE PA 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 GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS, AND DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. PA ON THE LEAD WAS COMPLETED ON (B)(6) 2013. NOTE THAT SINCE THE LEAD'S ELECTRODE AND ANCHOR TETHER HELIX WERE NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. THE LEAD ASSEMBLY HAS REMNANTS OF WHAT APPEARS TO BE DRY BODY FLUIDS INSIDE THE INNER AND THE OUTER SILICONE TUBING. HOWEVER NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED TUBING OPENINGS RELATED TO THE EXPLANT PROCEDURE. NO DISCONTINUITIES WERE IDENTIFIED DURING THE ANALYSIS. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATION, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. A REVIEW OF AVAILABLE PROGRAMMING HISTORY REVEALED NO ANOMALIES. THE LAST AVAILABLE INTERROGATION DATE WAS (B)(6) 2011. AT THAT TIME THE GENERATOR WAS ENABLED AND DIAGNOSTICS WERE WITHIN NORMAL LIMITS. FOLLOW UP PERFORMED WITH THE TREATING SURGEON WAS PERFORMED HOWEVER HE WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION AS HE INDICATED THAT THE PATIENT WAS EVALUATED BY A NEUROLOGIST AND HE WAS JUST ASKED TO REMOVE THE DEVICE. FOLLOW UP PERFORMED WITH THE LAST KNOWN TREATING NEUROLOGIST WAS PERFORMED AND IT WAS INDICATED THAT THEY HAD NOT SEEN THE PATIENT SINCE (B)(6) 2011. THE PAIN AND NUMBNESS HAD NOT BEEN REPORTED TO HIS OFFICE; HOWEVER HE DID INDICATE THAT THE PATIENT HAD BEEN EXPERIENCING HOARSENESS SINCE (B)(6) 2011. THE NEUROLOGIST DID INDICATE THAT THE PATIENT HAD FALLEN OFF HIS BIKE IN (B)(6) 2011, BUT HE WAS UNSURE IF THIS HAD CONTRIBUTED TO THE EVENT. NO OTHER INFORMATION WAS PROVIDED, AND ATTEMPTS TO DETERMINE A MORE RECENT PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2323

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention