BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD MODEL 300

    MDR report key: 2972994 · Received February 21, 2013

    Report

    Report Number
    1644487-2013-00459
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 28, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICES. REVIEW OF MANUFACTURING HISTORY RECORDS. REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED NO GROSS LEAD DISCONTINUITIES VISUALIZED. REVIEW OF LEAD MANUFACTURING HISTORY RECORDS CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN REPORTING THAT THERE DID NOT APPEAR TO BE A DIFFERENCE IN PATIENT SEIZURE FREQUENCY AFTER THE DEVICE STARTED MALFUNCTIONING. THE PATIENT'S RESPONSE IN YEARS PAST WAS REPORTED TO CONSIST OF CHANGES IN TYPES OF SEIZURES, E.G. MORE GENERALIZED TONIC CLONIC SEIZURES OCCURRED INSTEAD OF CLUSTERS OF TONIC SEIZURES IN THE PAST WITH CERTAIN CHANGES MADE. THEREFORE, IT WAS NOT OBVIOUS TO THE PHYSICIAN THAT THERE WAS A CLEAR REDUCTION EVER IN SEIZURE FREQUENCY WITH USE OF THE DEVICE. HE DID NOT KNOW WHEN THE LAST SYSTEM DIAGNOSTICS WERE PERFORMED THAT WERE WITHIN NORMAL LIMITS. A/P AND LATERAL IMAGES OF THE NECK AND CHEST WERE REVIEWED BY THE MANUFACTURER. BASED ON THE X-RAY IMAGES PROVIDED, AN EXACT CAUSE FOR THE REPORT OF HIGH IMPEDANCE COULD NOT BE DETERMINED. THE LEAD PINS APPEARED TO BE FULLY INSERTED INTO THE CONNECTOR BLOCKS. THE LEAD WIRE WAS INTACT AT THE LOCATION OF THE CONNECTOR PIN; HOWEVER THERE WAS A PORTION OF THE LEAD LOCATED BEHIND THE GENERATOR THAT COULD NOT BE ASSESSED. A PORTION OF THE LEAD BEHIND THE GENERATOR COULD NOT BE ASSESSED, THEREFORE A LEAD FRACTURE IN THAT PORTION OF THE LEAD CANNOT BE RULED OUT. THE PRESENCE OF A MICRO-FRACTURE IN THE LEAD ALSO CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    THE MANUFACTURER'S DISTRIBUTOR REPORTED THAT HIGH LEAD IMPEDANCE WAS OBSERVED ON A VNS PATIENT'S FOLLOW-UP VISIT ON (B)(6) 2013 ON A SYSTEM DIAGNOSTICS TEST. THE DEVICE WAS NOT TURNED OFF IMMEDIATELY AFTER OBSERVATION OF THE HIGH LEAD IMPEDANCE. RATHER, THE TREATING PHYSICIAN ELECTED TO SEMI-URGENTLY BRING THE PATIENT INTO THE HOSPITAL AS AN IN-PATIENT BEFORE THE DEVICE WAS TURNED OFF ON (B)(6) 2013. PA AND LATERAL CHEST AND NECK X-RAYS WERE PERFORMED. THE PHYSICIAN REPORTED THAT THEY ARE NOT THE GREATEST QUALITY. THE PHYSICIAN HAS REQUESTED THE RADIOLOGY DEPARTMENT FOR A COPY OF THE X-RAYS. ALTHOUGH RETURN OF A COPY OF THE X-RAYS MAY OCCUR IN THE FUTURE, THEY HAVE NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. THE PATIENT HAS NOT REPORTED CLINICAL SYMPTOMS AS A RESULT OF THE HIGH LEAD IMPEDANCE, BUT IS NOT ABLE TO DO SO DUE TO SEVERE NEUROLOGICAL IMPAIRMENT. THE FAMILY HAS NOT DETECTED ANY CLINICAL CHANGE TO SUGGEST HE IS SYMPTOMATIC. AT THIS TIME, THE PATIENT IS NOT BEING REFERRED FOR SURGERY. PER THE TREATING PHYSICIAN, IT IS NOT CLEAR THAT THE DEVICE HAS BEEN DOING HIM ANY GOOD IN THE PAST FEW YEARS. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75906 BIPOLAR LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-30 8434

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR