BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4080481 · Received September 11, 2014

    Report

    Report Number
    1644487-2014-02303
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 12, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    EVALUATION CODES, CONCLUSIONS; CORRECTED DATA: SUPPLEMENTAL MDR #01 INADVERTENTLY DID NOT UPDATE THE CONCLUSIONS OF THE EVENT BASED ON THE ADDITIONAL INFORMATION RECEIVED. WITH THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE WAS NOT TESTED VIA SYSTEM DIAGNOSTICS. THE PATIENT¿S DEVICE HAS NOT BEEN RE-TESTED VIA SYSTEM DIAGNOSTICS TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND NORMAL MODE DIAGNOSTICS REVEALED HIGH IMPEDANCE (DC DC ¿ 7). IT IS UNKNOWN WHETHER SYSTEM DIAGNOSTICS WERE ALSO PERFORMED. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND NORMAL MODE AND SYSTEM DIAGNOSTIC RESULTS REVEALED HIGH IMPEDANCE (DCDC ¿ 7). THE PHYSICIAN AND PATIENT ELECTED NOT TO PURSUE VNS REVISION SURGERY AS THE PATIENT DID NOT EXPERIENCE SEIZURE REDUCTION WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561836 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 6883

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR