BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3100865 · Received May 8, 2013

    Report

    Report Number
    1644487-2013-01249
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 9, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. REVIEW OF MANUFACTURING RECORDS PERFORMED. REVIEW OF MANUFACTURING HISTORY RECORDS OF THE LEAD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. X-RAYS REVIEWED BY 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

    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

    ANALYSIS OF THE GENERATOR WAS COMPLETED ON 01/22/2014. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS IN THE PA LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. ANALYSIS OF THE LEAD WAS COMPLETED ON 01/23/2014. 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 CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE LEAD 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 DISCONTINUITIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    A VNS TREATING PHYSICIAN REPORTED THAT THE PATIENT HAD A FOLLOW-UP APPOINTMENT ON (B)(6) 2013 AND HIGH LEAD IMPEDANCE WAS OBSERVED UPON PERFORMING SYSTEM AND NORMAL MODE DIAGNOSTICS (7/LIMIT/HIGH). THE PATIENT HAD NOTICED NOT FEELING THE STIMULATION AND HAD NOT EXPERIENCED VOICE CHANGE WHEN USING THE MAGNET SINCE ABOUT 2-3 WEEKS PRIOR. THE PHYSICIAN PROGRAMMED THE DEVICE OFF AS RECOMMENDED IN LABELING. THE PATIENT'S LAST VISIT WAS ON (B)(6) 2013 AT WHICH TIME THE PHYSICIAN TURNED THE DEVICE OFF FOR A MRI. SYSTEM DIAGNOSTICS PRIOR TO AND AFTER THE MRI WERE WITHIN NORMAL LIMITS. AFTERWARDS, THE PHYSICIAN TURNED THE DEVICE BACK ON. THE PATIENT EXHIBITED HIS NORMAL VOICE CHANGE WITH VNS STIMULATION, AND THE PATIENT ACTIVATED THE GENERATOR WITH THE VNS MAGNET. THEREFORE, THE PHYSICIAN REPORTED THAT SHE KNEW THAT THE VNS WAS WORKING AT THAT TIME. NO PATIENT MANIPULATION OR TRAUMA IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE PHYSICIAN PROVIDED X-RAY IMAGES TO THE MANUFACTURER FOR REVIEW AND REPORTED THAT FROM THE CHEST X-RAY EVERYTHING APPEARED INTACT. AP AND LATERAL X-RAYS OF THE CHEST AND NECK WERE REVIEWED BY THE MANUFACTURER. BASED ON THE X-RAYS RECEIVED THERE WERE NO VISIBLE ANOMALIES OR LEAD DISCONTINUITIES OBSERVED THAT COULD HAVE BEEN CAUSING THE REPORTED HIGH LEAD IMPEDANCE. HOWEVER, DUE TO THE IMAGE QUALITY AND DEVICE POSITIONING, THE ENTIRE LEAD BODY AND GENERATOR COULD NOT BE ASSESSED. ALTHOUGH REVISION SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR AND LEAD EXPLANT. IT WAS REPORTED THAT THE PATIENT WAS REFERRED FOR EXPLANT DUE TO LACK OF EFFICACY AND THAT THE PATIENT WAS NOT REIMPLANTED. THE LEAD AND GENERATOR WERE RECEIVED FOR ANALYSIS ON (B)(6) 2013. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    ATTEMPTS FOR THE PATIENT¿S DATE OF BIRTH HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201291 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 202000

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR