BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3092733 · Received May 3, 2013

    Report

    Report Number
    1644487-2013-01189
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION OCCURRED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED DUE INSERTION DIFFICULTIES. THE INSERTION DIFFICULTY WAS DUPLICATED IN THE LAB. THE IN-LINE CAVITY GO GAGE OR BENCH TEST LEADS WOULD NOT INSERT INTO THE NEGATIVE CONNECTOR BLOCK. THE INSERTION FAILURE WAS DUE TO THE CONNECTOR BLOCK NOT BEING FULLY INSERTED PAST THE RETENTION RAMP IN THE HEADER WHICH SECURES THE CONNECTOR BLOCK IN PLACE. RESULTS OF DIAGNOSTIC TESTING INDICATED THE DEVICE WAS OPERATING PROPERLY AND COMMUNICATED PROPERLY. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. A CAUSE FOR THE 'CONNECTOR BLOCK POSITION' ISSUE COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW WAS PERFORMED PRIOR TO DISTRIBUTION OF THIS GENERATOR AND ALL ITEMS PASSED PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT A SURGEON HAD INTRAOPERATIVE PROBLEMS WITH INSERTING THE LEAD INTO A NEW GENERATOR. HE TRIED TO INSERT THE LEAD INTO THE OLD GENERATOR WITHOUT ANY PROBLEMS. SYSTEM DIAGNOSTICS WERE OK. HIGH IMPEDANCE WAS NOTED WITH THE NEW GENERATOR; HOWEVER, IMPEDANCE WAS OK WITH THE OLD GENERATOR. THE GENERATOR WAS RETURNED AND IS UNDERGOING PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    REVIEW OF PROGRAMMING HISTORY FROM THE DATE OF SURGERY SHOWS THAT THE SUSPECT MEDICAL DEVICE WAS NEVER PROGRAMMED ON. SYSTEM AND GENERATOR DIAGNOSTICS WERE RUN. THE GENERATOR DIAGNOSTIC YIELDED NORMAL LIMITS, AND THE SYSTEM DIAGNOSTICS ALL YIELDED HIGH IMPEDANCE RESULTS. ADDITIONAL FOLLOW-UP SHOWED THAT THERE WAS NO DAMAGE NOTED ON THE GENERATOR OR THE GENERATOR PACKAGING. THERE WAS NO EXCESSIVE FORCE USED ON THE GENERATOR OR ANY PART OF THE SYSTEM. ANALYSIS OF THE ORIGINALLY EXPLANTED GENERATOR SHOWED THAT THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193830 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202093

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR