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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 02/01/2012
Event Type  Injury  
Event Description

It was reported that a pt who was implanted with wns in 2008 had a "malfunctioning device" in which the pt's heart rate decelerates during stimulation to around 30 beats per minute. The pt was using the magnet to stop the stimulation. No additional information was provided, and attempts for additional information have been unsuccessful to date.

 
Event Description

A hospital nurse reported on (b)(6) 2012, that the patient was in the hospital and had been experiencing bradycardia the past (b)(6) months, which was occurring with vns stimulation. The patient's normal heart rate is in the mid-high 60 bpm range, and her heart rate has been dropping down in the 20-30 bpm range. The patient's cardiologist recommended to turn the device off as he felt it may be the cause. The patient has seen both her family doctor and cardiologist about this, but the patient has not seen her vns physician as he is on vacation. They were planning on disabling the device. Follow up with the nurse confirmed that the device was disabled on (b)(6) 2012, the patient was discharged with it disabled. The nurse does not know if the device has been turned on again. A vns neurologist was able to come to the hospital and disable the device. The plan was for her to see her normally treating neurologist and psychiatrist to evaluate the next steps. She also reported that she was in the room when the neurologist performed the eeg. She said it was "remarkable" how much her heart rate changed with vns stimulation. When the patient would remove the magnet from the generator site, the rate would go down to the 30's, so the neurologist would instruct the patient to place the magnet over the device again and it would go back to normal again. The heart rate improved once the device was disabled. Attempts for additional information from the neurologist who treated the patient on (b)(6) 2012, the patient's normally treating neurologist, and psychiatrist have been unsuccessful to date.

 
Event Description

Additional information was received from the patient reporting that she needs a new dosing psychiatrist. She had been seeing a neurologist as she has had bradycardia issues recently where she had to be hospitalized and he turned off her vns at the end of june to see if that had any effect helping resolve the bradycardia. She reported that she has done well with vns and even came off some medication, but she is anxious to figure out what is going on with her bradycardia because she is concerned her depression will return without vns.

 
Manufacturer Narrative

Type of report follow-up #, corrected data: the supplemental report #3 inadvertently reported the follow up #2, but it should have reported it as follow up #3.

 
Event Description

The patient's psychiatrist reported that she recommended that the patient contact a neuroscience department, as the physician is not a vns treating physician. She is not aware of any causal or contributory programming or medication changes that preceded the onset of the patient's arrhythmia. The patient does not have a medical or family history of arrhythmia. The patient pinned the magnet near the generator to keep it turned off. No diagnostics were available, as the physician is not a vns treating physician and does not have a programming system. The details of the patient's bradycardia are reportedly unclear, but the psychiatrist noted that the patient reported that the heart rate dropped to 30 beats per minutes during the event and became dizzy. There were no reported traumatic events prior to arrhythmia. It was unknown if the patient had any triggers prior to the arrhythmia, and it did not occur following a medication change. It is unknown if the arrhythmia was related to vns stimulation, but it did not occur during diagnostics or setting changes, as the psychiatrist does not have a programming system. The psychiatrist attributes the arrhythmia to vns, but notes she is only basing this assessment on the patient's report. It is unknown if vns exacerbated or concurrently contributed to the arrhythmia. No interventions were taken to preclude a serious injury.

 
Manufacturer Narrative

The initial report inadvertently reported the incorrect event date, as the additional information from the psychiatrist revealed the date to be (b)(6) 2012. The initial report inadvertently reported the incorrect implant date.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 7705 8
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 Key2471851
Report Number1644487-2012-00495
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/02/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/23/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2008
Device MODEL Number102
Device LOT Number015852
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/19/2012
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/27/2006
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: 02/23/2012 Patient Sequence Number: 1
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