BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 3121883 · Received May 21, 2013

    Report

    Report Number
    1644487-2013-01486
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 26, 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

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF LEAD DEVICE HISTORY RECORDS CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT UNDERWENT LEAD REVISION SURGERY ON (B)(6) 2013 BECAUSE IT ¿STOPPED WORKING¿. THE EXPLANTED LEAD 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

    A NEUROLOGY OFFICE REPORTED THAT THEY HAD A VNS PATIENT WHOSE DEVICE SHOWS HIGH LEAD IMPEDANCE, WITH AN IMPEDANCE VALUE GREATER THAN 10000 OHMS. THIS WAS THE FIRST TIME THE PHYSICIAN WAS SEEING THIS PATIENT, SO THE PHYSICIAN DID NOT HAVE ANY PREVIOUS PROGRAMMING OR DIAGNOSTIC HISTORY FOR THIS PATIENT. THE PATIENT HAD MENTIONED THAT SHE WAS THE VICTIM OF A HIT-AND-RUN ACCIDENT WHERE SHE WAS A PEDESTRIAN AND WAS HIT BY A MOTOR VEHICLE. THE PATIENT DID NOT REMEMBER WHEN THIS OCCURED BUT DID STATE THAT IT HAPPENED AFTER SHE WAS IMPLANTED. THERE WAS NO PATIENT MANIPULATION REPORTED. THE PATIENT ALSO DESCRIBED HAVING PAIN IN HER NECK WITH MOVEMENT AND COULD NOT DETERMINE IF IT OCCURS WITH OR WITHOUT STIMULATION. THE PAIN STARTED AROUND THE SAME TIME THAT THE HIT-AND-RUN ACCIDENT OCCURED. SHE HAS NOT ANY RECENT INCREASES IN SEIZURES. THE PATIENT REPORTED VIA CLINIC NOTES RECEIVED THAT APPROXIMATELY A YEAR AGO/STATES HER LAST SEIZURE ACTIVITY WAS A LIGHT SEIZURE WHICH WAS 6 MOS AGO/HER SEIZURES CONSIST OF PETIT MAL. THE PATIENT¿S TYPICAL SEIZURES ARE COMPLEX PARTIAL. PAST TREATMENT HAS INCLUDED PHENYTOIN (DILANTIN) AND MYSOLINE. THEY HAD THEIR VNS PLACED (B)(6) 2012. TYPICAL SEIZURE SYMPTOMS: BLANK STARE, LOSS OF CONSCIOUSNESS AND FALLS. THE MOST RECENT SEIZURE OCCURRED 6 MONTH(S) AGO AND WAS TYPICAL. THE SEIZURES 8-9 PER YEAR AND LAST FOR 60 SECOND(S). THIS IS DESCRIBED AS UNCHANGED. EXACERBATING FACTORS: STRESS AND LACK OF SLEEP. THE PATIENT'S DEVICE WAS PROGRAMMED OFF (B)(6) 2013 AND THEY ARE BEING REFERRED FOR SURGERY. NO DATE HAS BEEN PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE LEAD. A SUSPECTED COIL BREAK HAS OCCURRED AT THE POSITIVE AND NEGATIVE LEAD COILS. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE AND NEGATIVE COIL SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE ENDS OF THE LEAD COILS. ALSO, APPEARANCE OF BOTH THE POSITIVE AND NEGATIVE COILS SUGGEST A STRESS-INDUCED FRACTURED (MOST LIKELY DUE TO ROTATIONAL FORCES) HAS OCCURRED AT THE COIL ENDS. ALSO, SECONDARY FRACTURES WERE IDENTIFIED IN THE VICINITY OF THE COIL ENDS. APPEARANCE OF THE NEGATIVE COIL SUGGESTS PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE DISCOLORED AREA. THE OUTER TUBING IS ABRADED OPEN. THE LEAD ASSEMBLY SHOWS CHARACTERISTICS SUGGESTING PATIENT MANIPULATION OF THE IMPLANTED DEVICE, A ¿TWIDDLER¿ AT THE LEAD BODY (TUBING COMPRESSED\TWISTED) AND PAST THE ELECTRODE BIFURCATION (COILS SPIRAL APPEARANCE). OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S OFFICE ASKED THE MANUFACTURER'S REPRESENTATIVE TO NOT COPY THE PROGRAMMING/DIAGNOSTIC DATA FROM THE PHYSICIAN'S PROGRAMMING HANDHELD COMPUTER. ATTEMPTS FOR PROGRAMMING DATA WERE UNSUCCESSFUL TO DATE. IT WAS REPORTED THAT THE PATIENT WILL HAVE LEAD REVISION, AND THE GENERATOR WILL NOT BE REPLACED. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224689 LEAD MODEL 304 LEAD MODEL 304 LYJ CYBERONICS, INC. 304-30 3267

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR