BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 100

    MDR report key: 3063010 · Received April 17, 2013

    Report

    Report Number
    1644487-2013-01045
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    April 29, 2004
    Report Date
    March 25, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF MANUFACTURING HISTORY RECORDS PERFORMED. REVIEW OF MANUFACTURING HISTORY RECORDS CONFIRMED THAT ALL QUALITY TESTS WERE PASSED FOR THE LEAD PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR AND LEAD WERE DISPOSED OF BY THE EXPLANTING FACILITY IN 2004.

    Description of Event or Problem · 1

    DURING A RETROSPECTIVE REVIEW OF MANUFACTURER'S IN-HOUSE PROGRAMMING/DIAGNOSTIC HISTORY DATABASE, IT WAS OBSERVED THAT ON (B)(6) 2004, THE PATIENT'S SYSTEM DEVICE DIAGNOSTICS REVEALED HIGH LEAD IMPEDANCE HIGH WAS ONE MONTH PRIOR TO THE PATIENT'S GENERATOR REPLACEMENT DUE TO SUSPECTED END OF SERVICE. ONE WEEK PRIOR ON (B)(4) 2004, SYSTEM DIAGNOSTICS WERE WITHIN NORMAL LIMITS. IT WAS REPORTED BY THE HOSPITAL THAT THE GENERATOR WAS EXPLANTED DUE TO SUSPECTED END OF SERVICE ON (B)(6) 2004 BUT THERE WAS NO MENTION OF THE LEAD BEING REPLACED AT THAT TIME. FOLLOW-UP WITH THE TREATING PHYSICIAN AT THAT TIME REVEALED THAT HIGH LEAD IMPEDANCE WAS OBSERVED WITH DCDC=7. THE LEAD WAS ORIGINALLY PLACED IN 1999 AND WAS REPLACED IN ADDITION TO THE GENERATOR ON (B)(6) 2005. NO ADDITIONAL INFORMATION WAS PROVIDED. ATTEMPTS FOR PRODUCT RETURN HAVE UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    REVIEW OF THE GENERATOR PROGRAMMING AND DIAGNOSTIC HISTORY FOR THE REPLACEMENT GENERATOR THAT IS AVAILABLE IN THE MANUFACTURER'S DATABASE SHOWS ENTIRELY NORMAL DIAGNOSTIC RESULTS FROM IMPLANT TO EXPLANT. OPERATIVE AND MEDICAL NOTES FROM THE DATE OF SURGERY CONFIRMED THAT THE LEAD WAS NOT REPLACED AS PREVIOUSLY REPORTED; ONLY THE GENERATOR WAS REPLACED. THE HIGH IMPEDANCE RESOLVED WITH THE IMPLANTATION OF THE REPLACEMENT GENERATOR. AS THIS GENERATOR WAS A M100 AND THE DEVICE WAS REPORTED TO BE AT END OF SERVICE, THE OPERATIVE AND MEDICAL RECORDS FROM DATE OF SURGERY CONFIRMS THE LEAD WAS NOT REPLACED. AS A RESULT, THERE IS SUFFICIENT EVIDENCE THAT THE LIKELY CAUSE OF DCDC-7 HIGH LEAD IMPEDANCE WAS DUE TO NORMAL END OF SERVICE . THE M100/M101 PHYSICIAN'S MANUAL REFERENCES THIS AS A POSSIBLE CAUSE OF HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165265 PULSE GEN MODEL 100 GENERATOR LYJ CYBERONICS, INC. 100 17789C

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR