BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 6821623 · Received August 25, 2017

    Report

    Report Number
    1644487-2017-04374
    Event Type
    Injury
    Date Received
    August 25, 2017
    Date of Event
    July 1, 2017
    Report Date
    December 29, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT INCLUDE FULL CONTEXT OF REASON WHY DIAGNOSTIC TESTING WAS NOT PERFORMED.

    Description of Event or Problem · 1

    CLINIC NOTES INDICATED THAT A PATIENT UNEXPECTEDLY HAD AN AURA AND A SEIZURE PRIOR TO A RECENT CLINIC VISIT. THE PHYSICIAN NOTED THAT THE PATIENT WAS COMPLIANT WITH HER MEDICATION AND FOUND NO OBVIOUS CAUSE FOR THE SEIZURES. THE PHYSICIAN ATTRIBUTED THE RECENT SEIZURES TO VNS BATTERY DEPLETION, GIVEN THE FACT THAT THE PATIENT'S DEVICE HAD BEEN IMPLANTED FOR OVER 9 YEARS. THE PHYSICIAN DID NOT PERFORM DIAGNOSTICS TESTS ON THE PATIENT'S DEVICE SINCE THE PATIENT'S SETTINGS WERE LOWER THAN SYSTEM DIAGNOSTIC TEST PARAMETERS. DIAGNOSTIC TEST RESULTS FROM THE YEAR PRIOR WERE WITHIN THE NORMAL LIMITS. THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT SURGERY. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR WAS RECEIVED BY THE MANUFACTURER, BUT ANALYSIS HAS NOT BEEN APPROVED FOR THE GENERATOR TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS WAS APPROVED FOR THE GENERATOR. VISUAL EXAMINATION OF THE GENERATOR IDENTIFIED DID NOT IDENTIFY ANOMALIES WITH THE GENERATOR EXTERIOR. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS UNABLE TO PERFORM DIAGNOSTIC TESTS ON THE PATIENT'S DEVICE SINCE THE PATIENT COULD NOT TOLERATE THE SYSTEM DIAGNOSTIC TEST PARAMETERS FOR HER DEVICE. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600826 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200774

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention