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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 10/01/2012
Event Type  Malfunction  
Event Description

A vns patient's caregiver reported that the patient was having "a lot of problems" since her last cluster that started (b)(6) 2012, which included one grand mal seizure. The patient and caregiver reportedly talked to the treating vns physician on (b)(4) 2012. The caregiver indicated that he was "pretty sure that the vns device is causing problems and may be malfunctioning somehow". The device was reportedly disabled for periods of time on (b)(6) 2012, and the patient feels much better with the device disabled. The caregiver was leaving the vns magnet taped over the device to keep the device disabled. The caregiver was planning on having the patient evaluated by the treating physician to perform diagnostic tests. Attempts for additional information from the treating physician have been unsuccessful to date.

 
Event Description

The patient had an appointment with the treating vns physician on (b)(6) 2013, and the company representative attended the appointment. The clinic notes for the office visit were received and reviewed. The patient's device was turned off on (b)(6) 2012, but the magnet output current was left at 1. 0ma so she could still swipe the magnet when she feels a seizure coming on. The interval month was met with a lessening in frequency and intensity of partial epilepsy. The patient has utilized this feature, per the clinic notes. The device was turned off because of tachycardia arrhythmia and epigastric pain and pyrosis which was felt potentially to be aggravated by the vns. The patient was wearing an monitor from the cardiologist, and the arrhythmia reportedly stopped after the device was turned off. She did not have any more episodes. The epigastric pain and pyrosis is believed to have begun around the same period of time as the arrhythmia. The physician does not believe the device is malfunctioning, as diagnostics are within normal limits. However, the physician noted that it is of interest that the patient has not had any cardiac sinus tachyarrhythmia or epigastric pain/pyrosis since the device normal output current has been turned off. The physician notes there is a questionable relationship of these events to vns therapy, and the epigastric pain/pyrosis is suspicious for vagotonia. At this time, the plan is to keep the device turned off (except magnet mode) and monitor the patient. Previously on (b)(6) 2012, the physician mentioned that the patient had a high pulse rate at 140 bpm at a previous dosing session (unknown date) but later dropped to 106 bpm. The physician did not think the issue was related to the vns at the time, but did refer the patient to cardiologist for evaluation. The physician noted at that time that nothing was found.

 
Manufacturer Narrative

 
Event Description

Additional information was received indicating the patient was seen by the physician again on (b)(6) 2013, and the patient/spouse and physician elected to turn the device on to low settings at 0. 25ma. All is reportedly well with the patient at this time and the patient will continued to be monitored.

 
Event Description

Additional information was received from the patient indicating that she was taken to emergency room in (b)(6) 2012 due to tachycardia experienced during vns stimulation. She denied any reoccurrence of tachycardia since vns was "turned down. ".

 
Manufacturer Narrative

Age at time of event, corrected data: additional information received indicates the event date was around (b)(4) 2012, and therefore, the initial report inadvertently reported the age incorrectly. Outcomes attributed to adverse event, corrected data: the initial report inadvertently did not list that intervention was taken. Date of event, corrected data: additional information received indicates the event date was around (b)(4) 2012, and therefore, the initial report inadvertently reported the date incorrectly.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2899181
Report Number1644487-2013-00065
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/08/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/07/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2014
Device MODEL Number103
Device LOT Number3314
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received02/28/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/17/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/07/2013 Patient Sequence Number: 1
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