BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2232245 · Received September 2, 2011

    Report

    Report Number
    1644487-2011-02053
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE VNS TREATING PHYSICIAN'S ASSISTANT REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. NO FURTHER INFORMATION WAS REPORTED AT THAT TIME GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN HAVE BEEN TO NO AVAIL THUS FAR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011 WHEN CLINIC NOTES DATED (B)(6) 2011 WERE RECEIVED FROM THE PHYSICIAN INDICATING THAT THE PATIENT HAS HAD SOME AURAS AND IS SEEING THE PHYSICIAN FOR VNS PROGRAMMING ADJUSTMENT. THE PATIENT'S SETTINGS WERE OUTPUT=3.5MA/FREQUENCY=30HZ/PULSE WIDTH=250USEC/ON TIME=60SEC/OFF TIME=1.8MIN/MAGNET OUTPUT=3.5MA/ON TIME=60SEC/PULSE WIDTH=500. THE CASE MANAGER REPORTED THAT THE PATIENT IS BEING REFERRED FOR BATTERY REPLACEMENT DUE TO AN INCREASE IN SEIZURES. THE PATIENT HAD BATTERY REPLACEMENT ON (B)(6) 2011 AND THE CASE MANAGER REPORTED THAT THE NEUROLOGIST SAID THAT THE PATIENT IS HAVING SOME ISSUES SINCE HER REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER'S CONSULTANT LATER REPORTED THAT THE REASON FOR BATTERY REPLACEMENT WAS NOT BECAUSE OF THE INCREASE IN SEIZURES, BUT WAS BECAUSE OF A LOW BATTERY. THE OPERATION NOTES FROM THE BATTERY REPLACEMENT SURGERY WERE RECEIVED AND THEY MENTIONED NOTHING ABOUT ANY ISSUES AFTER THE BATTERY REPLACEMENT SURGERY. THE OPERATION NOTES STATE THAT AFTER SURGERY THE PATIENT WAS PROGRAMMED TO OUTPUT=3.5MA/FREQUENCY=30HZ/PULSE WIDTH=250USEC/ON TIME=60SEC/OFF TIME=1.8MIN/MAGNET OUTPUT=3.5MA/MAGNET ON TIME=60SEC/MAGNET PULSE WIDTH=500USEC AND DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL. GOOD FAITH ATTEMPTS FOR THE RETURN OF THE EXPLANTED GENERATOR TO THE MANUFACTURER FOR PRODUCT ANALYSIS HAVE BEEN MADE BUT THE GENERATOR HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2012, WHEN PRODUCT ANALYSIS ON THE EXPLANTED GENERATOR WAS COMPLETED. THE BATTERY WAS FOUND TO BE PARTIALLY DEPLETED WITH 2.608V AND NEAR END OF SERVICE=YES. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES WITH THE GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHEN THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS ON (B)(6), 2012. PRODUCT ANALYSIS ON THE GENERATOR IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(4) 2011, ADDITIONAL INFORMATION WAS RECEIVED WHEN THE MANUFACTURER'S CONSULTANT REPORTED THAT THE PHYSICIAN STATED THE PATIENT'S UNSPECIFIED ISSUES AFTER THE BATTERY REPLACEMENT SURGERY ON (B)(6) 2011 HAD RESOLVED. THE PHYSICIAN WOULD NOT PROVIDE DETAILS REGARDING WHAT THE UNSPECIFIED ISSUES WERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2604

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR