BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3955498 · Received July 24, 2014

    Report

    Report Number
    1644487-2014-01862
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    March 1, 2014
    Report Date
    June 26, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, 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 OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR AND LEAD WERE RETURNED ON (B)(6) 2014. AN ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTIONS. DURING THE VISUAL ANALYSIS OF THE RETURNED LEAD, THE POSITIVE CONNECTOR RING QUADFILAR COIL APPEARED TO BE BROKEN APPROXIMATELY 282MM AND 285MM FROM THE END OF THE CONNECTOR BOOT. SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON THE POSITIVE CONNECTOR RING QUADFILAR COIL BREAK AND IDENTIFIED THE AREAS AS HAVING EVIDENCE OF A STRESS INDUCED FRACTURE WITH MECHANICAL DAMAGE, AND EVIDENCE OF A STRESS INDUCED FRACTURE, WHICH MOST LIKELY COMPLETED THE FRACTURE. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO OTHER DISCONTINUITIES WERE IDENTIFIED. NO OTHER OBVIOUS ANOMALIES WERE NOTED. ANALYSIS ON THE EXPLANTED PULSE GENERATOR WAS PERFORMED. RESULTS OF DIAGNOSTIC TESTS DEMONSTRATE THAT ACCURATE RESISTANCE MEASUREMENTS WERE OBTAINED IN ALL INSTANCES. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY, 3.035 VOLTS, SHOWS AN IFI=NO CONDITION. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEAD WAS "RUPTURED" DUE TO AN AUTO ACCIDENT HE HAD IN (B)(6). IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT THE DAY PRIOR. THE GENERATOR WAS REPLACED PROPHYLACTICALLY. IT WAS REPORTED THAT THE EXPLANTED DEVICES WENT TO PATHOLOGY AND WILL BE RETURNED FOR ANALYSIS WHEN COMPLETED. THE EXPLANTED DEVICES HAVE NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433491 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 845

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR