BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 4120748 · Received September 26, 2014

    Report

    Report Number
    1644487-2014-02491
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY DID NOT PROVIDE THE CORRECT EVENT DATE. BRAND NAME; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY DID NOT PROVIDE THE CORRECT SUSPECT DEVICE FOR THE EVENT. TYPE OF DEVICE, NAME; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY DID NOT PROVIDE THE CORRECT SUSPECT DEVICE FOR THE EVENT. MODEL #, SERIAL #, LOT#, EXPIRATION DATE; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY DID NOT PROVIDE THE CORRECT SUSPECT DEVICE FOR THE EVENT. OPERATOR OF DEVICE; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY DID NOT PROVIDE THE CORRECT OPERATOR OF THE DEVICE FOR THE EVENT. DEVICE MANUFACTURE DATE; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY DID NOT PROVIDE THE CORRECT SUSPECT DEVICE FOR THE EVENT. EVALUATION, CONCLUSIONS; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY DID NOT PROVIDE THE CORRECT CONCLUSION CODING FOR THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE REPORTED HIGH IMPEDANCE CONDITION OF THE VNS PATIENT¿S DEVICE WAS INVALID. HIGH IMPEDANCE WAS NOT OBSERVED AND THE EVENT WAS REPORTED BY AN INDIVIDUAL WITH A LIMITED UNDERSTANDING OF VNS. THE PATIENT¿S DEVICE WAS TESTED ON (B)(6) 2014 AND LEAD IMPEDANCE WAS FOUND TO BE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECENTLY IMPLANTED VNS PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND SYSTEM DIAGNOSTIC RESULTS REVEALED HIGH IMPEDANCE. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE. NO FURTHER INFORMATION RELEVANT TO THE REPORTED HIGH IMPEDANCE EVENT HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601870 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS, INC. 103 3750

    Patients

    Seq Age Sex Outcome Treatment
    1