BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 3192266 · Received June 27, 2013

    Report

    Report Number
    1644487-2013-01939
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT DURING DIAGNOSTICS, HIGH IMPEDANCE WAS OBSERVED. A SYSTEM DIAGNOSTICS TEST SHOWED A DCDC OF 6 AND A NORMAL MODE DIAGNOSTICS TEST SHOWED A DCDC OF 5. SHE TRIED TURNING THE PATIENT¿S HEAD TO THE RIGHT AND THEN THE LEFT WHILE DIAGNOSTICS WERE PERFORMED AND THE DCDC CODES WERE THE SAME. IT WAS REPORTED THAT X-RAYS MAY BE PERFORMED BUT IT WAS UNKNOWN IF THEY WOULD BE SENT TO THE MANUFACTURER FOR REVIEW. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 6.12 YEARS REMAINING UNTIL ERI=YES. THE PATIENT¿S LEAD PRODUCT INFORMATION WAS REQUESTED FROM THE IMPLANTING HOSPITAL BUT IT HAS NOT BEEN RECEIVED. IT WAS LATER REPORTED THAT THE PATIENT WILL NOT BE GOING FOR REVISION SURGERY AT THIS TIME AS THE PATIENT¿S MOTHER DOES NOT BELIEVE THE PATIENT IS BENEFITTING FROM THERAPY. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN WERE MADE BUT NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    THE PHYSICIAN LATER REPORTED ON (B)(6) 2013 THAT THE DEVICE WAS NOT DISABLED DESPITE THE HIGH IMPEDANCE. HE ALSO STATED THAT X-RAYS WERE NOT TAKEN AS THE PATIENT¿S MOTHER REFUSED THEM. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE PHYSICIAN ALSO STATED THAT THE BELIEVED CAUSE FOR THE LACK OF EFFICACY IS THAT THE PATIENT IS A NON-RESPONDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293506 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR