BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 2792491 · Received October 16, 2012

    Report

    Report Number
    1644487-2012-02397
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    July 17, 2009
    Report Date
    September 17, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Additional Manufacturer Narrative · 1

    PATIENT AGE AT TIME OF EVENT, CORRECTED DATA - PREVIOUSLY SUBMITTED MDR INDICATED THE INCORRECT PATIENT AGE. THE PATIENT WAS (B)(6) AT THE TIME OF THE EVENT. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION.

    Description of Event or Problem · 1

    DURING REVIEW OF PROGRAMMING HISTORY ON (B)(6) 2012, IT WAS IDENTIFIED THAT THIS PATIENT'S GENERATOR EXPERIENCED A PULSE DISABLED EVENT DUE TO VBAT<EOS THRESHOLD ON THE DATE OF GENERATOR IMPLANT ((B)(6) 2009). TWO INTERROGATIONS AT THE TIME OF IMPLANT WERE PERFORMED. THE FIRST (10:04:33 AM) INDICATED THAT THE DEVICE WAS PROGRAMMED TO DELIVER THERAPY; HOWEVER, THE SECOND INTERROGATION (10:05:19 AM) INDICATED A PULSE DISABLED EVENT. A SYSTEM DIAGNOSTIC PERFORMED AT 9:56:32 AM SHOWED NORMAL RESULTS. A SYSTEM DIAGNOSTIC AT 10:04:53 AM INDICATED 0 MONTHS TO EOS. THE PATIENT'S DEVICE WAS EXPLANTED FOR PROPHYLACTIC REASONS AND RETURNED FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS FOR THE GENERATOR WAS APPROVED ON (B)(6) 2012. THE PREMATURE EOL WAS DUPLICATED IN THE PA LAB. THE BATTERY WAS FOUND TO BE PARTIALLY DEPLETED AND AT NEOS. DURING A DIAGNOSTIC TEST ATTEMPT, THE VOLTAGE DROPPED TO 2.188 VOLTS, WHICH SHOWS THAT THE BATTERY IS DEPLETED WHEN THE DEVICE ATTEMPTS TO ENTER A FUNCTIONAL MODE. 14.833% OF THE BATTERY HAD BEEN CONSUMED. A REVIEW OF THE PROGRAMMING HISTORY REVEALED THAT THE DEVICE HAD BEEN DISABLED DUE TO EOS DURING THE IMPLANT PROCEDURE. POST BURN-IN ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. A REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    AN IMPLANT CARD RECEIVED ON (B)(4) 2013 INDICATED THAT THE PATIENT UNDERWENT GENERATOR REVISION ON (B)(6) 2012 DUE TO NEAR END OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 201095

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR