BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3241589 · Received July 22, 2013

    Report

    Report Number
    1644487-2013-02214
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 28, 2012
    Report Date
    June 28, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ATTEMPTS FOR ADDIITIONAL INFORMATION AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT THE VNS PATIENT RECEIVED A FULL REVISION ON JUNE 28, 2013 DUE TO LEAD DISCONTINUITY. INFORMATION REGARDING THE REASON FOR THE VNS GENERATOR REPLACEMENT WAS NOT PROVIDED. BATTERY LIFE CALCULATIONS WERE PERFORMED AND IT WAS REVEALED THAT THE VNS DEVICE HAS 2.87 YEARS LEFT UNTIL END OF SERVICE. GOOD FAITH ATTEMPTS HAVE BEEN DELAYED BECAUSE THE PHYSICIAN WILL NOT BE RETURNING TO THE OFFICE UNTIL THE END OF (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341044 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 30536C

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention