BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3091951 · Received May 3, 2013

    Report

    Report Number
    1644487-2013-01233
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    October 21, 2010
    Report Date
    April 3, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT OR PRODUCT PROBLEM, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE EVENT WAS ONLY A MALFUNCTION; HOWEVER, THE PATIENT ALSO EXPERIENCED NECK AND CHEST PAIN AS A RESULT OF THE REPORTED MALFUNCTION AND SURGICAL INTERVENTION WAS TAKEN INDICATING THAT THE PAIN SHOULD BE REPORTABLE AS A SERIOUS INJURY. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION. OUTCOMES, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR OMITTED AN ASSOCIATED OUTCOME ASSOCIATED WITH THE ADVERSE EVENT. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION. RELEVANT DATA, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR OMITTED DIAGNOSTIC RESULTS. THIS REPORT IS BEING SUBMITTED TO CORRECT/ADD THIS INFORMATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE GENERATOR AND LEAD WERE DISCARDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE (>10000 OHMS). THE PATIENT WAS IN A CAR WRECK IN 2010 AND IT IS UNKNOWN IF THEY MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE HIGH IMPEDANCE AND POTENTIAL LEAD BREAK. X-RAYS WERE ORDERED AND BUT NO X-RAYS HAVE BEEN PROVIDED TO THE MANUFACTURER FOR REVIEW BUT THE REQUEST HAS BEEN MADE FOR THEM TO BE PROVIDED. THE PATIENT IS ALSO EXPERIENCING BURNING SENSATION IN THE LEFT CHEST AND NECK OCCUPATIONALLY WHEN THE PATIENT TURNS HER HEAD TO THE LEFT OFF AND ON SINCE (B)(6) 2012. THE LEAD IMPEDANCE INCREASED FROM 2923 OHMS TO >10000 OHMS WHEN THE PATIENT TURNS HIS NECK. THE PATIENT WANTED TO LEAVE THE VNS AS IT IS THE ONLY THING CONTROLLING HIS SEIZURES AND HE WILL AVOID TURNING HIS NECK. THE PATIENT HAD A GENERATOR AND LEAD REPLACEMENT. PRODUCT RETURN ATTEMPTS ARE IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194912 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 285

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other