BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 3081120 · Received April 26, 2013

    Report

    Report Number
    1644487-2013-01176
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    January 2, 2013
    Report Date
    April 8, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED DEVICE PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A LEAD REPLACEMENT DUE TO ¿SPIRALING¿ AND MAYBE SOME ¿MANIPULATION¿. THE GENERATOR WAS NOT REPLACED. THE MANUFACTURER¿S CONSULTANT STATED THAT DURING SURGERY TWO SYSTEM DIAGNOSTICS TESTS WERE PERFORMED PRIOR TO SURGERY AND THEY FOUND HIGH LEAD IMPEDANCE WITH AN IMPEDANCE VALUE OF GREATER THAN 8,000 OHMS. UPON OPENING THE GENERATOR POCKET, IT WAS FOUND THAT HIS GENERATOR HAD BROKEN LOOSE FROM ITS 3.0 PROLENE ANCHOR AND THIS HAD CAUSED THE GENERATOR TO SPIN SEVERAL TIMES IN THE POCKET WHICH IS WHAT WAS BELIEVED TO HAVE LED TO THE LEAD BREAK. THE SURGEON WAS NOT CONVINCED IT WAS DUE TO PATIENT MANIPULATION OR IF IT MAY HAVE HAPPENED WHEN THE PATIENT IS SLEEPING AND MOVING IN HIS SLEEP. HOWEVER, TI WAS CLEAR THAT THE GENERATOR HAD SPUN SEVERAL TIMES IN THE POCKET. THE PATIENT WAS NOTED TO WEIGH (B)(6) AND DOES NOT HAVE MUCH IN THE LINE OF BODY FAT TO HELP PROTECT THE GENERATOR FROM MANIPULATION. THE SPUN WIRES COULD BE SEEN IN THE LEAD WIRE. THE GENERATOR APPEARED TO BE FUNCTIONING PROPERLY UPON IMPLANT OF A NEW LEAD. SYSTEM DIAGNOSTICS WITH THE NEW LEAD SHOWED RESULTS WITHIN NORMAL LIMITS (1550 OHMS RANGE). PRODUCT ANALYSIS ON THE LEAD WAS COMPLETED ON (B)(4) 2013. SCANNING ELECTRON MICROSCOPY IMAGES OF THE CONNECTOR PIN SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE AREAS WHERE AN OPAQUE APPEARANCE WAS NOTED. THE EXACT REASON FOR THIS CONDITION IS UNKNOWN. NO ADVERSE EFFECT WAS IDENTIFIED ON THE DEVICE PERFORMANCE AS A RESULT OF THIS CONDITION. SINCE THE ELECTRODE ARRAY PORTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. THE LEAD ASSEMBLY HAS REMNANTS OF WHAT APPEARS TO BE DRY BODY FLUIDS INSIDE THE INNER AND THE OUTER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE END OF THE RETURNED LEAD PORTION. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION.

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT DURING NORMAL MODE DIAGNOSTIC TESTING, HIGH IMPEDANCE WAS OBSERVED. DURING A NORMAL MODE DIAGNOSTICS TEST ON (B)(6) 2013, HIGH IMPEDANCE WAS OBSERVED WITH AN IMPEDANCE VALUE OF 9800 OHMS. REPEAT TESTING TWO TIMES CAME IN AT 3800 OHMS AND 3900 OHMS, WHICH IS UNCHANGED AND IN THE NORMAL RANGE FOR THE PATIENT. THE PULSE FREQUENCY WAS INCREASED FROM 10 TO 20 HZ WITHOUT ANY OBVIOUS SIDE EFFECTS. HIGH IMPEDANCE WAS AGAIN SEEN ON (B)(6) 2013. IT WAS REPORTED THAT NO TRAUMA HAD OCCURRED, HOWEVER THE PHYSICIAN BELIEVED THAT PATIENT MANIPULATION MAY HAVE OCCURRED, BUT THIS WAS NOT CONFIRMED. THE DEVICE WAS DISABLED ON (B)(6) 2013 AND THE PATIENT WAS SCHEDULED FOR REVISION SURGERY. PRIOR TO THE REVISION SURGERY THE PHYSICIAN PLANS TO CHECK THE LEAD PIN INSERTION AND THEN PERFORM A FULL REVISION IF THE HIGH IMPEDANCE ISSUE WAS NOT RESOLVED. ADDITIONALLY, THE PHYSICIAN HAS DECIDED AGAINST TAKING X-RAYS AS SURGICAL INTERVENTION HAS ALREADY BEEN PLANNED. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182257 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 3326

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R