BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3132087 · Received May 29, 2013

    Report

    Report Number
    1644487-2013-01605
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 1, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THE DEVICE MET ALL FINAL TESTING SPECIFICATIONS AND STERILIZATION STANDARDS PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WOULD UNDERGO REVISION SURGERY DUE TO THE VNS NEARING END OF LIFE AND HIGH IMPEDANCE. CLINIC NOTES WERE RECEIVED WHICH MENTION THAT THE HIGH IMPEDANCE COULD BE DUE TO A FRACTURE IN THE LEAD OR SCAR TISSUE. REVIEW OF THE DEVICE MANUFACTURING RECORDS FOR THE LEAD INDICATES THAT THE LEAD PASSED ALL FINAL SPECIFICATION TESTING PRIOR TO DISTRIBUTION. FOLLOW UP WITH THE SURGEON'S OFFICE CONFIRMED THAT THE EXPLANT WAS DUE TO END OF SERVICE AND HIGH LEAD IMPEDANCE. NO REPORTS OF TRAUMA WERE KNOWN. IT WAS STATED THAT X-RAYS WILL NOT BE PERFORMED AS THE NURSE PRACTITIONER STATED THAT IT IS UNLIKELY THE PATIENT WILL COOPERATE AS SHE HAS SEVERE MENTAL RETARDATION. THE PATIENT'S SETTINGS WERE PROVIDED AS 1.5MA, 30HZ, 250MSEC, 30SEC, 1.1MIN, 2.0MA, 60 SEC, 250MSEC. IT WAS UNKNOWN IF THE DEVICE WAS PROGRAMMED OFF AFTER THE HIGH IMPEDANCE WAS OBSERVED. CLINIC NOTES FROM THE NEUROLOGY DEPARTMENT WERE PROVIDED, WHICH HAD THE PATIENT'S SETTINGS AND DIAGNOSTIC INFORMATION. IT WAS STATED THAT THE HIGH IMPEDANCE WAS FIRST OBSERVED IN NEUROLOGY ON (B)(6) 2013. THE PATIENT WAS SEEN BY THE SURGEON ON (B)(6) 2013. NO OTHER INFORMATION WAS PROVIDED. THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT THE REPLACEMENT SURGERY TOOK PLACE ON (B)(6) 2013. PER RISK MANAGEMENT AT THE HOSPITAL, THE EXPLANTED DEVICES WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235290 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-30 7808C

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR