BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 4112933 · Received September 24, 2014

    Report

    Report Number
    1644487-2014-02438
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR AND LEAD EXPLANT. THE EXPLANTED GENERATOR AND LEAD WERE RECEIVED FOR ANALYSIS. THE RETURNED PRODUCT FORM NOTED THAT THE DEVICES WERE EXPLANTED DUE TO "ADVERSE EVENT." ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(4) 2014. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. VISUAL INSPECTION RESULTS REVEALED NO EXTERNAL DEVICE ABNORMALITIES. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. ANALYSIS OF THE LEAD WAS COMPLETED ON (B)(4) 2014. THE LEAD ASSEMBLY WAS RETURNED INTACT. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. CONTINUITY CHECKS OF THE RETURNED LEAD ASSEMBLY WERE PERFORMED WITH NO DISCONTINUITIES IDENTIFIED. OVERALL LENGTH AND RESISTANCE MEASUREMENTS OF THE COMPLETE RETURNED LEAD WERE DETERMINED TO BE IN COMPLIANCE WITH THOSE DEFINED IN THE MANUFACTURING SPECIFICATIONS. A REVIEW OF THE GENERATOR DECODER INDICATED THAT AT THE TIME OF EXPLANT THE DEVICE LEAD IMPEDANCE WAS 2477 OHMS, INDICATING THAT THE LEAD IMPEDANCE WAS FINE UP UNTIL DAY OF EXPLANT. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE WAS EXPLANTED DUE TO INFECTION. THE PATIENT HAS NOT BEEN RE-IMPLANTED TO DATE. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596082 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202019

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention