BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3182287 · Received June 21, 2013

    Report

    Report Number
    1644487-2013-01879
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT UNDERWENT LEAD REVISION ON (B)(6) 2013. THE EXPLANTED LEAD WAS DISCARDED BY THE HOSPITAL AND THEREFORE CANNOT BE RETURNED FOR PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PATIENT¿S GENERATOR WAS NOT ABLE TO BE INTERROGATED BY THE NEUROLOGIST BUT THE NURSE WAS ABLE TO INTERROGATE THE GENERATOR WITH NO PROBLEMS DURING SURGERY AND DID FIND DCDC=7. AFTER THE GENERATOR WAS EXPLANTED, THE NURSE STATED THAT A DIAGNOSTICS TEST WAS PERFORMED USING THE TEST RESISTOR AND HAD NORMAL RESULTS. THE REPLACEMENT GENERATOR WAS INTERROGATED SUCCESSFULLY DURING SURGERY AND THREE DIAGNOSTICS TESTS WERE PERFORMED WITH RESULTS OF HIGH IMPEDANCE FOUND DURING THE SECOND TEST, BUT NOT THE FIRST OR THIRD TEST. IT WAS STATED THAT THE IMPEDANCE SEEMED TO FLUCTUATE DEPENDING ON THE POSITION OF THE PATIENT. THE PATIENT¿S REPLACEMENT GENERATOR WAS LEFT PROGRAMMED OFF AND THE PATIENT WOULD BE PROGRAMMED BACK ON DURING CLINIC. IT WAS STATED THAT IF HIGH IMPEDANCE IS FOUND DURING CLINIC, THAT THE MANUFACTURER WOULD BE NOTIFIED. THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS ON (B)(4) 2013. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    GENERATOR ANALYSIS WAS APPROVED ON (B)(6) 2013. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS IN THE PA LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR, AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. REVIEW OF ADDITIONAL PROGRAMMING SHOWS THAT THE GENERATOR WAS PROGRAMMED OFF ON (B)(6) 2006. THE DEVICE WAS INTERROGATED AT THE SAME DISABLED SETTINGS ON (B)(6) 2013. THE DEVICE WAS PROGRAMMED ON AND THEN PROGRAMMED OFF. A SYSTEM DIAGNOSTIC ON (B)(6) 2013 INDICATED HIGH IMPEDANCE.

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT HE VNS PATIENT HAS BEEN EXPERIENCING STRONG AURAS FOR THE LAST 24 HOURS WHICH HE HAD STOPPED HAVING WITH THE VNS. THE PATIENT INDICATED THAT HE HAS NOT HAD HIS VNS CHECKED IN YEARS, ONLY HAD IT TURNED ON AND OFF FOR MRIS. THE PATIENT WENT TO SEE THE PHYSICIAN LATER THAT DAY AND HIGH IMPEDANCE WAS OBSERVED DURING SYSTEM DIAGNOSTICS TEST. IT WAS ALSO FOUND THAT THE GENERATOR WAS DISABLED UPON INTERROGATION (REPORTED ON MFR. REPORT # 1644487-2013-01880) AND THERE WAS NO INDICATION OF WHEN OR WHY IT WAS SET TO 0 MA. THE PHYSICIAN WAS UNSURE IF THE VNS HAD ANYTHING TO DO WITH THE PATIENT¿S STRONG AURAS. THERE WAS NO KNOWN TRAUMA OR MANIPULATION AND THE PATIENT WAS NOT REFERRED FOR X-RAYS. REVIEW OF THE PATIENT¿S PROGRAMMING HISTORY REVEALED THAT THE PATIENT WAS DISABLED ON (B)(6) 2006 BUT IT IS UNKNOWN IF THIS WAS FOR AN MRI THAT THE PATIENT PREVIOUSLY REPORTED HIS DEVICE HAD BEEN TURNED ON AND OFF FOR AND IF THE PATIENT¿S DEVICE WAS TURNED ON AGAIN AFTERWARDS OR LEFT OFF UNTIL THE PRESENT INTERROGATION. THE NURSE WHO DID THE PROGRAMMING ON (B)(6) 2006 WAS CONTACTED FOR ADDITIONAL INFORMATION BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. THE PATIENT WAS SEEN ON (B)(6) 2013 FOR A SURGICAL CONSULT AND IT WAS INDICATED THAT THE PATIENT HAD BECOME SEIZURE FREE AND WAS WEANED OFF OF HIS MEDICATION BUT HAS A RECENT RECURRENCE OF ¿AURAS¿. THE PATIENT UNDERWENT A GENERATOR REPLACEMENT ON (B)(6) 2013 AND WHEN THE GENERATOR WAS REPLACED, THE IMPEDANCE WAS FOUND TO BE NORMAL. HOWEVER, AFTER CHECKING THE IMPEDANCE ONCE THE PATIENT WAS CLOSED UP, HIGH IMPEDANCE WAS AGAIN OBSERVED. IT WAS REPORTED TO SEEM TO FLUCTUATE DEPENDING ON THE POSITION OF THE PATIENT. THE PATIENT WAS REFERRED FOR A LEAD REVISION SURGERY. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282802 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 6883

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR