BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2880109 · Received December 19, 2012

    Report

    Report Number
    1644487-2012-03398
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    June 30, 2009
    Report Date
    November 26, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT; CORRECTED DATA: ADDITIONAL INFORMATION WAS RECEIVED WHICH CHANGES THE EVENT DATE FROM WHAT WAS INITIALLY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE PATIENT WAS PREVIOUSLY DIAGNOSED WITH SUPRAVENTRICULAR TACHYCARDIA (SVT). THE MOTHER INDICATED THAT THE SVT OCCURS WHEN THE PATIENT'S GENERATOR IS TURNED UP TO HIGH. NO ADDITIONAL INFORMATION WAS PROVIDED AT THAT TIME.ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT HAD INITIALLY BEEN REPORTED THAT THE PATIENT IS PASSING OUT WHICH THE MOTHER FEELS COULD BE DUE TO THE SUPRAVENTRICULAR TACHYCARDIA (SVT). THIS EVENT OCCURS WHEN THE VNS IS TURNED UP TOO HIGH. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN THE PHYSICIAN REPORTED THAT THE PATIENT WAS PROGRAMMED TO AN OUTPUT OF 0.25MA , FREQUENCY OF 25HZ, AND PULSE WIDTH OF 250USEC UNTIL (B)(6) 2009, WHEN THE PATIENT COMPLAINED OF INCREASED HEART RATE WHEN THE VNS STIMULATION WAS ON. THE PATIENT ASKED AT THAT TIME THAT THE STIMULATION BE TURNED OFF. THE PATIENT WAS REFERRED TO A CARDIAC ELECTROPHYSIOLOGY SUB-SPECIALIST. ON (B)(6) 2009 THE PATIENT REQUESTED THAT THE VNS BE REPROGRAMMED TO RESUME STIMULATION AFTER STATING THAT SHE BELIEVED SOME OF HER CARDIAC ISSUES MAY HAVE BEEN RELATED TO NON-NEUROLOGICAL MEDICATION CHANGE. THE DEVICE WAS THEREFORE PROGRAMMED TO OUTPUT = 0.25MA, SIGNAL FREQUENCY = 20HZ, PULSE WIDTH = 130 USEC, TIME ON = 21 SECONDS, MAGNET PULSE WIDTH = 250 USEC. OVER APPROXIMATELY TWO YEARS, THE PARAMETERS WERE VERY GRADUALLY RE-TITRATED WITHOUT RECURRENCE OF CARDIAC SIGNS OR SYMPTOMS. DURING A CLINIC VISIT IN JULY 2012, NO SEIZURES WERE REPORTED, AND THE PATIENT DENIED ANY ADVERSE EFFECTS OR EVENTS RELATED TO THE VNS. BECAUSE OF THE PATIENT'S PRIOR REPORT OF INTOLERANCE TO VERY CONSERVATIVE STIMULATION PARAMETERS, AND BECAUSE HER DEVICE WAS A MODEL 102, THE PHYSICIAN STATED THAT THE PROBABLE BENEFIT OF RUNNING A STANDARD SYSTEM DIAGNOSTICS ROUTINE (WHICH WOULD STIMULATE AT 1.0 MA) WAS OUTWEIGHED BY THE RISK OF ADVERSE EFFECTS. THE PATIENT'S CARDIAC ELECTROPHYSIOLOGIST'S NURSE STATED THAT THE PATIENT WAS DIAGNOSED WITH SVT IN 2009; HOWEVER THEY HAVE NOT SEEN THE PATIENT SINCE THEN. SHE STATED THAT THERE WAS NO INDICATION FROM THEIR NOTES THAT THE SVT WAS RELATED TO VNS BACK THEN, AND AS THEY HAVE NOT SEEN THE PATIENT SHE COULD NOT PROVIDE ANY ASSESSMENT OF THE PATIENT'S CURRENT SITUATION. SHE INDICATED THAT USUALLY, THE PATIENTS WILL UNDERGO FURTHER TESTING TO DETERMINE THE CAUSE OR THE SVT AND THE SEIZURE EFFECT, HOWEVER PER THEIR NOTES; THE PATIENT HAD NOT DONE THIS. SHE INDICATED THAT THEY WOULD NOT BE ABLE TO PROVIDE ANY ADDITIONAL INFORMATION ON THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 016030

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other