BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2863664 · Received December 10, 2012

    Report

    Report Number
    1644487-2012-03260
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    March 1, 2012
    Report Date
    November 8, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: FOLLOW-UP REPORT #1 INADVERTENTLY REPORTED THAT THAT VNS WAS THE CAUSE OF THE DEPRESSION BUT IT SHOULD HAVE READ THAT VNS IS NOT THE CAUSE OF THE DEPRESSION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS HAVING AN INCREASE IN DEPRESSION DUE TO THE PATIENT'S MEDICATION (ALBUTERIN) FORMULARY BEING CHANGE BY THE PHARMACY. THE PHYSICIAN INCREASED THE PATIENT'S SETTINGS IN AN ATTEMPT TO HELP WITH THE DEPRESSION WITH NO IMPROVEMENT. THE PATIENT HAS BEEN DOING WORSE AND THE PHYSICIAN IS CONCERNED THAT VNS MAY NOT BE WORKING LIKE IT USE TO. THE PATIENT'S INCREASE IN DEPRESSION IS STILL BELOW HIS PRE-VNS BASELINE. THERE ARE NO DIAGNOSTIC AVAILABLE FOR THE PATIENT TO CONFIRM THE GENERATOR AND LEAD ARE FUNCTIONING CORRECTLY. THERE WAS NO REPORTED TRAUMA OR PATIENT MANIPULATION BUT THAT THERE MAY HAVE BEEN REGULAR LIFE EVENTS THAT COULD HAVE BEEN A CONTRIBUTING FACTOR. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORT THAT THE PATIENT WAS DOING WORSE WAS REFERRING TO THE INCREASE IN DEPRESSION. THERE IS NOT DEVICE MALFUNCTION SUSPECTED. THE PATIENT HAS YEARLY WINTER SADNESS AS PART OF HIS NORMAL DEPRESSION PATTERN AND AGAIN GOT SADDENED IN (B)(6). THIS YEAR WHEN THAT OCCURRED THEY WERE NO CONCERNED AS IT WAS BELIEVED TO BE NORMAL AS PART OF HIS PATTERN. WHEN THE PATIENT CAME IN THEY WOULD ASK HIM IF HE WAS STILL TAKING HIS 2 PILLS A DAY AND HE SAID HE WAS. IT WAS NOT UNTIL HIS DEPRESSION WAS WORSE FOR A COUPLE MONTHS THAT IT WAS DETERMINED THAT PATIENT WAS NOT TAKING THE CORRECT DOSE. THE PATIENT WAS TO BE TAKING 400 MG PER DAY (TWO 200 MG TABLETS) BUT THE PHARMACY STARTED GIVING HIM 100 MG TABLETS INSTEAD OF 200 MG TABLETS AND AS A RESULT HE WAS TAKING HALF THE PRESCRIBED DOSE. THIS WAS THE CAUSE OF THE INCREASE IN DEPRESSION, WHICH IS CURRENTLY STILL BELOW BASELINE. ONCE THE PATIENT HAD THE INCREASE IN DEPRESSION THEY ARE HAVING TROUBLE GETTING HIM BACK TO WHERE HE WAS BEFORE BUT HE HAS IMPROVED. THE PATIENT HAS BEEN HAVING ECT TREATMENTS FIRST AS AN INPATIENT AND NOW EVERY TWO WEEKS AS AN OUT-PATIENT. AS HE IMPROVES THEY WILL CONTINUE MOVING THIS FURTHER APART. THE PATIENT HAD ECT TREATMENTS A LOT PRIOR TO VNS AND HAS NOT HAD TO HAVE ANY SINCE VNS (UNTIL THIS PAST YEAR) SINCE HE DID SO WELL WITH VNS. THE PATIENT IS PURSUING GENERATOR REPLACEMENT AND THE PHYSICIAN FEEL THAT THE GENERATOR BEING NEAR END OF SERVICE MAY BE THE REASON THAT THE PATIENT IS NOT ABLE TO GET BACK TO DEPRESSION (W/ VNS) BASELINE BUT VNS IS THE CAUSE OF THE DEPRESSION. THE PHYSICIAN STATED THAT THE GENERATOR WAS NOT DEAD YET AND THAT PATIENT WAS STILL RECEIVING THEORY. THE PATIENT HAS NOT HAD SURGERY TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS CONTINUED TO HAVE OUTPATIENT ECT EVERY THREE WEEKS. THE OFFICE IS REALLY HAPPY WITH HIS PROGRESS AND HE IS DOING MUCH BETTER. IT IS UNCLEAR IF THE IMPROVEMENT IS DUE TO THE GENERATOR REPLACEMENT, ECT OR BOTH BUT WHAT IS IMPORTANT IS THAT HE IS DOING BETTER. NO SUICIDAL IDEATION OR OTHER ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. 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. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A GENERATOR REPLACEMENT. THE GENERATOR WAS 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
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 013755

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR