BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 2023002 · Received February 24, 2011

    Report

    Report Number
    1644487-2011-00338
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVIEW OF PROGRAMMING HISTORY RECEIVED FROM THE SITE ON THE DATE THAT THE EVENT OCCURRED DID NOT SHOW EVIDENCE OF THE REPORTED EVENT OF UNEXPECTED DISABLEMENT. THERE PATIENT'S DEVICE WAS NOT DISABLED AND THERE WERE NO WARNING MESSAGES ABOUT THE DEVICE BEING DISABLED THAT WAS SEEN ON THE PROGRAMMING HISTORY. THE DATA SHOW THAT THE DEVICE WAS INTERROGATED ON (B)(6) 2011 AT THE PREVIOUS PROGRAMMED SETTINGS FROM THE PRIOR OFFICE VISIT AND THERE IS NO INDICATION THAT THE DEVICE WAS DISABLED AND THE BATTERY STATUS INDICATOR ON THAT DATE WAS OK.

    Description of Event or Problem · 1

    FURTHER REVIEW OF PROGRAMMING DATA FORM THE PHYSICIAN¿S HANDHELD REVILED THAT THERE WAS ANOTHER PATIENT THAT DATE THAT HAD VBAT<EOS. THE PHYSICIAN MAY HAVE CONFUSED THE PATIENT WHEN HE CONTACTED THE MANUFACTURE AND REPORTED THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2011 THAT A VNS HAD BEEN SEEN ON (B)(6) 2011. UPON INITIAL INTERROGATION, THE PATIENT'S GENERATOR HAD BEEN FOUND TO BE DISABLED DUE TO AN END-OF-SERVICE (EOS) CONDITION. THE PT AS THEN REPROGRAMMED TO 2.25 MA/25 HZ/130 MICROSEC/21 SEC/0.8 MIN. SYSTEM DIAGNOSTICS WERE PERFORMED AND RESULTS SHOWED EOS. SETTINGS FOR THE GENERATOR HAD BEEN 1.75 MA/25 HZ/130 MICROSEC/21 SEC/0.8 MIN SINCE IMPLANT, WHICH WAS THEN INCREASED TO 2 MA/25 HZ/130 MICROSEC/21 SEC/0.8 MIN ON (B)(6) 2010. THE PT HAD EXPERIENCED A BREAKTHROUGH SEIZURE. THE PHYSICIAN STATED HE "KNOWS THE DEVICE IS NOT AT EOS BECAUSE THE PT IS IMPLANTED LESS THAN 1 YEAR AND THERE IS NO WAY THE GENERATOR IS AT EOS". (B)(4) ATTEMPTS TO DATE FOR MORE INFO REGARDING THE EOS CONDITION OF THE GENERATOR HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 104 LYJ CYBERONICS, INC. 104 201043

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR