BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2211867 · Received August 10, 2011

    Report

    Report Number
    1644487-2011-01839
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    April 10, 2009
    Report Date
    July 20, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER (MO/DAY/YR), CORRECTED DATA. FOLLOW-UP REPORT #1 INADVERTENTLY LISTED THE AWARE DATE AS (B)(6) 2011, WHICH WAS THE AWARE DATE FOR THE INITIAL REPORT. THE CORRECT AWARE DATE FOR THE FOLLOW-UP #1 REPORT SHOULD HAVE BEEN (B)(6) 2011.

    Description of Event or Problem · 1

    A REVIEW OF PT PROGRAMMING DATA REVEALED THAT DURING THE PT'S INITIAL FOLLOW UP VISIT ((B)(6) 2009) AFTER IMPLANT SURGERY ((B)(6) 2009) A "VBAT < EOS THRESHOLD" WARNING MESSAGE WAS RECEIVED INDICATING THAT THE PT'S DEMIPULSE GENERATOR WAS LIKELY IN THE PRESENCE OF ELECTROCAUTERY CAUSING AN ASIC LATCH-UP CONDITION DURING THE IMPLANT PROCEDURE. AS A RESULT OF THIS EXPOSURE THE CAPACITY OF THE GENERATORS BATTERY WAS ALTERED LEADING TO AN ATYPICAL DEPLETION STATE. THE GENERATOR WAS RETURNED AND REPORTED IN MDR # 1644487-2011-01531 DUE TO A PREMATURE EOS ALLEGATION. AN END-OF-SERVICE WARNING MESSAGE WAS VERIFIED IN THE PRODUCT ANALYSIS LAB AND FOUND TO BE ASSOCIATED WITH THE OUTPUT BEING DISABLED BY THE PULSE GENERATOR. POST BURN-IN ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WAS A CAPACITOR THAT WAS MEASURED TO BE OUT-SPECIFICATION BUT HAD NO ADVERSE EFFECT ON DEVICE FUNCTIONALITY. THE BATTERY IS DEPLETED, 1.56 VOLTS AS MEASURED WITH THE CAN REMOVED AND BATTERY STILL ATTACHED TO THE PCB. THE DATA IN THE MEMORY LOCATIONS REVEALED THAT 34.928% OF THE BATTERY HAD BEEN CONSUMED.

    Description of Event or Problem · 1

    ATTEMPTS WERE MADE FOR OPERATIVE NOTES FOR THE IMPLANT AND EXPLANT OF THE GENERATOR HOWEVER THEY WILL NOT BE PROVIDED AS IT IS AGAINST THEIR POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS INC 103 201025

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR