BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2770418 · Received October 3, 2012

    Report

    Report Number
    1644487-2012-02501
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 10, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEW OF X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER. NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    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.

    Description of Event or Problem · 1

    THE PATIENT HAD REVISION SURGERY (B)(6) 2012. THEIR EXPLANTED LEAD HAS BEEN RETURNED FOR ANALYSIS AND COMPLETION IS PENDING. AN ENGINEER WAS PRESENT AT THE OPERATING ROOM ON (B)(6) 2012. THE LEAD IMPEDANCE WAS ASSESSED THROUGH SYSTEM DIAGNOSTICS AND IT WAS FOUND TO BE HIGH, WITH DCDC CODE 7 AND OUTPUT STATUS LIMIT. THE PULSE GENERATOR WAS EXPLANTED AND A REPLACEMENT GENERATOR WAS CONNECTED TO THE ORIGINALLY IMPLANTED LEAD. THE LEAD IMPEDANCE WAS ASSESSED AGAIN, THROUGH SYSTEM DIAGNOSTICS OF THE REPLACEMENT GENERATOR. THE AFOREMENTIONED RESULTS (LEAD IMPEDANCE HIGH, OUTPUT STATUS LIMIT, DCDC CODE 7) WERE OBTAINED AGAIN AND A LEAD REPLACEMENT WAS INITIATED. UPON CONNECTION OF THE REPLACEMENT GENERATOR TO THE REPLACEMENT LEAD, SYSTEM DIAGNOSTICS WERE RUN AND THE RESULTS WERE WITHIN NORMAL RAGES (DDC CODE 1, LEAD IMPEDANCE OK, OUTPUT STATUS OK). THE EXPLANTED GENERATOR WAS KEPT BY THE IMPLANTING HOSPITAL AND IT WILL BE DISPOSED OF IN THEIR OWN FACILITIES. FIBROSIS WAS NOTED AT THE ELECTRODE SITES. NO CAUSE OTHER THAN THE DEVICE IS KNOWN AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED LEADS. THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. DURING THE VISUAL ANALYSIS THE CONNECTOR PIN QUADFILAR COIL APPEARED TO BE BROKEN APPROXIMATELY 337 MM FROM THE END OF THE CONNECTOR BOOT. SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON AND IDENTIFIED THE AREA AS HAVING EXTENSIVE PITTING AND MECHANICAL DAMAGE WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE. IT IS BELIEVED THAT STIMULATION WAS PRESENT FOR A CERTAIN PERIOD OF TIME AS EVIDENCED BY THE PRESENCE OF METAL PITTING. LOW MAGNIFICATION SEM ANALYSIS OF THE QUADFILAR COIL SHOWS CHARACTERISTICS TYPICAL OF A LEAD DISCONTINUITY WHICH MAY INCLUDE: MATERIAL FRACTURE, ROUGH OR PITTED SURFACE, THINNED MATERIAL THICKNESS, ELECTRO-ETCHING OR MATERIAL DISSOLUTION. WHAT APPEARED TO BE INCLUSIONS WERE OBSERVED ON SOME OF THE COIL STRANDS. EDS (ENERGY DISPERSION SPECTROSCOPY - PROVIDES CHEMICAL OR ELEMENT IDENTITY/COMPOSITION ANALYSIS) WAS PERFORMED ON THE INCLUSIONS. THE ANALYSIS RESULTS SHOW THE PRESENCE OF ELEMENTS CONSISTENT WITH THE MP35N MATERIAL. DURING THIS ANALYSIS THE EXACT IMPACT THE INCLUSIONS MADE TO THE OBSERVED FRACTURE COULD NOT BE DETERMINED. HOWEVER, RESULTS OF AN ENERGY DISPERSION SPECTROSCOPY (EDS) EVALUATION DEMONSTRATE THAT THE COMPOSITION OF MATERIALS IN THESE AREAS ARE REPRESENTATIVE OF THE COIL MATERIAL, SO THE CONDITION IS NOT EXPECTED TO HAVE AN ADVERSE EFFECT. THE ABRADED OPENING FOUND ON THE OUTER SILICONE TUBING, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS FOUND INSIDE THE OUTER SILICONE TUBING. WITH THE EXCEPTION OF THE OBSERVED DISCONTINUITY, THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE MARKED CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO OTHER DISCONTINUITIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO OUR COUNTRY REPRESENTATIVE IN (B)(6) THAT THERE WAS A PATIENT WITH HIGH LEAD IMPEDANCE. THE PATIENT'S GENERATOR WAS INTERROGATED ON (B)(4) 2012. SYSTEM DIAGNOSTIC TESTING RESULTED IN A DCDC=2 AND DIAGNOSTICS NORMAL MODE DCDC=4.. HIGH LEAD IMPEDANCE, DCDC 7 WAS DETECTED ON (B)(6) 201,2 DURING THE DEVICE'S INTERROGATION. THEIR DEVICE SWITCHED OFF AT THIS TIME. NO FURTHER INFORMATION HAS BEEN ATTAINED AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S HIGH IMPEDANCE WAS CAUSED BY POSSIBLE TRAUMA, SINCE THE PATIENT EXPERIENCES FREQUENT DROPS. THE PATIENT WILL BE SEEN BY A SURGEON IN THE COMING WEEKS. NO DATE SET AT THIS TIME. AP AND LATERAL CHEST AND AP AND LATERAL NECK X-RAYS WERE RECEIVED FOR REVIEW. REVIEW OF THE X-RAYS INDICATED THE FOLLOWING: THE GENERATOR IS PLACED IN A NORMAL LOCATION IN THE UPPER LEFT CHEST. THE FILTER FEED-THROUGH WIRES APPEARED TO BE INTACT. THE LEAD CONNECTOR PIN APPEARED TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE LEAD WIRES AT THE CONNECTOR PIN APPEARED TO BE INTACT. THE NEGATIVE AND POSITIVE ELECTRODE APPEARED TO BE CORRECTLY ALIGNED ON THE VAGAL NERVE. A STRAIN-RELIEF BEND WAS PRESENT. NO STRAIN-RELIEF LOOP WAS PRESENT. ONE TIE-DOWN HAD BEEN USE, PLACED A FEW CENTIMETERS FURTHER TOWARDS THE GENERATOR, TO HOLD THE UPPER THIRD OF THE LEAD BODY. NO TIE-DOWN WAS USED TO HOLD THE STRAIN-RELIEF BEND. PER LABELING, A STRAIN RELIEF BEND SHOULD BE PLACED STARTING 3 CM FROM THE ANCHOR TETHER AND SHOULD BE SECURED WITH A TIE-DOWN PARALLEL TO THE ANCHOR TETHER. A LARGE LOOP SHOULD THEN BE FORMED AND SECURED WITH AN ADDITIONAL TIE-DOWN TO ALLOW FOR FULL NECK MOVEMENT IN ALL DIRECTIONS. PORTIONS OF THE LEAD APPEARED TO BE BEHIND THE GENERATOR AND COULD NOT BE FULLY ASSESSED. NO GROSS FRACTURES OR SHARP ANGLES COULD BE IDENTIFIED. BASED ON THE X-RAYS IMAGES, NO EVIDENT CAUSE FOR THE HIGH IMPEDANCE COULD BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD MODEL 302 LYJ CYBERONICS, INC. 302 2423

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR