BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3841576 · Received May 30, 2014

    Report

    Report Number
    1644487-2014-01388
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    BRAND NAME; CORRECTED DATA: PRODUCT INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE EXPLANTED DEVICES WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS AND PRODUCT INFORMATION WAS OBTAINED. ANALYSIS OF THE GENERATOR CONCLUDED THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WAS NO INDICATION FROM THE DEVICE THAT AN END OF SERVICE CONDITION EXISTED. ANALYSIS OF THE RETURNED LEAD PORTION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND DIAGNOSTIC RESULTS REVEALED HIGH IMPEDANCE (DC DC ¿ 7). THE DEVICE WAS RETESTED WITH THE SAME RESULTS. THE LAST NORMAL DIAGNOSTIC RESULTS WERE SIX MONTHS PRIOR TO THIS OFFICE VISIT. X-RAYS WERE TAKEN AND THE IMAGES SHOWED THE LEAD TANGLE APPROXIMATELY 8CM FROM THE PATIENT¿S GENERATOR THAT WAS APPROXIMATELY 2CM IN DIAMETER. PATIENT MANIPULATION IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE PATIENT WAS REFERRED FOR SURGERY BUT NO KNOWN INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE VNS PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO LEAD DISCONTINUITY. THE EXPLANTED GENERATOR AND LEAD HAVE NOT BEEN RETURNED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED LEAD PORTION WAS COMPLETED. NOTE THAT A LARGE PORTION OF THE LEAD ASSEMBLY INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE SLICE MARKS AND ABRADED OPENING FOUND ON THE OUTER SILICONE TUBING AND THE CUT ENDS THAT WERE MADE DURING THE EXPLANTED PROCESS, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR THE DRIED REMNANTS OF WHAT APPEARED TO HAVE ONCE BEEN BODY FLUIDS FOUND INSIDE THE OUTER SILICONE TUBING. EXCEPT FOR THE ABRADED OPENING IN THE OUTER TUBING, THERE WERE NO OBSERVED PRODUCT RELATED ISSUES WITH THE RETURNED LEAD PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318421 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 5625C

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR