BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 2914442 · Received January 14, 2013

    Report

    Report Number
    1644487-2013-00094
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

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

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS APPROVED ON (B)(4) 2013. SCANNING ELECTRON MICROSCOPY IMAGES OF THE NEGATIVE COIL SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE BREAK LOCATIONS. A BROKEN STRAND WAS IDENTIFIED. DUE TO METAL DISSOLUTION, AND/OR MECHANICAL DISTORTION (SMOOTHED SURFACES) AND SURFACE CONTAMINATION THE FRACTURE MECHANISM OF THE BROKEN ENDS CANNOT BE DETERMINED. INSPECTION OF THE STRAND SEGMENTS SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED ON THE STRANDS. SCANNING ELECTRON MICROSCOPY IMAGES OF THE NEGATIVE COIL PERFORMED AT THE DARK APPEARANCE REGION SUGGEST ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THIS REGION. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTIONS. A LEAD ASSEMBLY WAS RETURNED FOR ANALYSIS IN THREE PIECES. ABRASIONS WERE IDENTIFIED ON THE OUTER SILICONE TUBING AT MULTIPLE LOCATIONS. TWO SETS OF SETSCREW MARKS WERE SEEN ON THE CONNECTOR PIN, PROVIDING EVIDENCE THAT PROPER CONTACT BETWEEN THE SETSCREW AND THE LEAD PIN EXISTED AT LEAST ONCE. ALSO, THE CONNECTOR RING HAS SCRATCHES MOST LIKELY CAUSED BY THE CANTED SPRING IN THE PULSE GENERATOR HEADER DURING INSERTION OF THE LEAD CONNECTOR. THE EXACT POINT IN TIME OF WHEN THIS OCCURRED IS UNKNOWN. ABRASIONS WERE NOTED ON THE CONNECTOR BOOT. THE OUTER SILICONE TUBING HAS ABRADED OPENINGS. THE INNER SILICONE TUBING OF THE NEGATIVE COIL ABRADED OPEN. THE INNER SILICONE TUBING OF THE POSITIVE COIL IS ABRADED OPEN. A BREAK IN NEGATIVE LEAD COIL WAS IDENTIFIED. A PORTION OF THE NEGATIVE COIL IS NOT VISIBLE. RADIOGRAPHIC EXAMINATION OF THE NEGATIVE COIL IDENTIFIED A BREAK AND VERIFIED THE COIL BREAK. A SEGMENT OF THE NEGATIVE COIL WAS REMOVED FROM THE TUBING TO PERFORM SEM INSPECTION. SEGMENTS OF STRANDS WERE IDENTIFIED AT THIS THE BREAK LOCATION. A TIE-DOWN WAS PRESENT ON THE LEAD BODY. THE TIE-DOWN HAS CUTS MOST LIKELY CAUSED DURING THE EXPLANT PROCEDURE. THE OUTER SILICONE TUBING HAS CUT OPENINGS. THE TIE-DOWN WAS REMOVED AND ABRASIONS DUE TO ITS PRESENCE WERE IDENTIFIED AT THIS LOCATION. THE LEAD ASSEMBLY IS CUT AT APPROXIMATELY 0.2CM PAST THE ELECTRODE BIFURCATION. THE LEAD IS COVERED WITH WHAT APPEARS TO BE ORGANIC MATTER. A PORTION OF A GREEN SUTURE WAS ATTACHED TO THE ORGANIC MATTER. THE EXACT ORIGIN OF THIS SUTURE IS CANNOT BE DETERMINED. A PORTION OF THE ANCHOR TETHER SUTURE APPEARS CUT. THE LEAD COILS ARE KINKED/NICKED. THE SILICONE TUBING APPEARS TO HAVE BEEN PUNCTURED AT THIS LOCATION. THE INNER SILICONE TUBING OF THE NEGATIVE COIL HAS A CUT OPENING. THE SILICONE TUBING OF THE POSITIVE COIL HAS A SUPERFICIAL. ABRASIONS WERE IDENTIFIED ON THE SILICONE TUBING OF THE LEAD COILS. A CUT OPENING WAS IDENTIFIED IN THE SILICONE TUBING OF THE POSITIVE COIL. AN OPENING IN THE SILICONE TUBING OF THE NEGATIVE COIL WAS IDENTIFIED AT THE ANCHOR TETHER AND AT 1CM PAST THE ANCHOR TETHER. NO ANOMALIES WERE IDENTIFIED ON THE ANCHOR TETHER HELIX. BOTH THE CLOSEST AND THE FURTHEST ELECTRODE TO THE BIFURCATION ARE DAMAGED SHOWING CREASES/BENDS ON THE ELECTRODE RIBBON AND PARTIAL DETACHMENT OF THE ELECTRODE RIBBON FROM THE SILICONE HELIX. A PORTION OF THE SILICONE HELIX (NOT RETURNED) OF THE FURTHEST ELECTRODE TO THE BIFURCATION APPEARS TO HAVE BEEN CUT. THE NEGATIVE COIL HAS A DARK APPEARANCE IN THE VICINITY OF THE FURTHEST ELECTRODE. RADIOGRAPHIC EXAMINATION OF THE NEGATIVE COIL AT THIS LOCATION WAS PERFORMED AND NO ANOMALIES WERE NOTED. 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 IDENTIFIED TUBING OPENINGS AND THE ENDS OF THE RETURNED LEAD PORTIONS. BASED ON THE APPEARANCE OF THE RETURNED LEAD PORTIONS, IT IS BELIEVED THAT THE IDENTIFIED PUNCTURES, KINKS, SUPERFICIAL CUTS, AND CUT OPENINGS WERE MOST LIKELY CAUSED DURING THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT A PATIENT UNDERWENT LEAD REVISION ON (B)(6) 2012 DUE TO A LEAD DISCONTINUITY. THE EXPLANTED LEAD WAS RECEIVED ON (B)(6) 2012 AND IS CURRENTLY UNDERGOING PRODUCT ANALYSIS. A RETURN PRODUCT FORM INDICATED THAT THE DEVICE WAS EXPLANTED DUE TO A LEAD DISCONTINUITY AND THAT A REPLACEMENT UNIT WAS IMPLANTED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. PROGRAMMING HISTORY FOR (B)(6) 2012 SHOWS THAT IMPEDANCE WAS WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19808 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 201702

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR