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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 07/04/2011
Event Type  Injury  
Event Description

Additional information was received from the patient indicating that the patient is still experiencing pain in her face, however an overall 80% improvement in her depression. The pain stated a couple of months prior to this report. The pain started as tooth pain. The patient then had to tooth removed and the pain was then being felt on the left side of the face radiating up to the skull. The pain reportedly occurs every 5 minutes for 1 minute, and there are no reported issues when disabled with the magnet. This is consistent with the on and off times of the patient's current settings. It was also reported that the patient's pulse width was lowered from 500usec to 250usec; however the date when this was done is unknown. The patient has since been seen by multiple surgeons. A ct scan and x-rays were performed but showed no abnormality. It is unclear if the x-rays will be sent to the manufacturer for review. One surgeon reported that he attempted different settings to determine if the patient still felt pain, and then programmed the patient off to see if she could feel the difference. The patient was able to tell when on versus off and reported intermittent pain in face. The surgeon feels that the patient may feel the stimulation and due to her other psychological issues, she may associate it with pain, even though the diagnostic test was normal. Specific diagnostic results were not provided. The surgeon also recommended that the patient go back to her treating neurologist to adjust settings. The surgeon ordered ct scans and will only re-position (exploratory) as a last option. Currently the patient leaves her device on for half of the day and disables the device with the magnet for the other half. Attempts for additional information have been unsuccessful to date.

 
Event Description

Additional information was received from the surgeon indicating that the device was failing and no longer working for the patient. Diagnostics, performed since the onset of this issue, have been found to be normal, indicating that device failure is not suspected. Attempts for additional information have been unsuccessful to date.

 
Manufacturer Narrative

Supplemental report 1 incorrectly left the event as a malfunction; however intervention has since been taken.

 
Event Description

A vns pt implanted for depression called and reported that a couple months ago, her psychiatrist changed two parameters on her generator but she did not know what those were. After this, about 3 weeks ago, she started experiencing pain in her neck around the electrode site and up further on her neck. The pt reported that the pain sometimes travels up around the left side of her head and in her jaw and teeth. It was the first time the pt had experienced this pain since implant. The pt had not had any fall or injury preceding the event and it only occurred when her device was on and did not occur during the off times. The pt had used her magnet to temporarily help the pain a couple of times but didn't leave the magnet there for an extended period of time. Their reported pain goes away when the magnet is taped over the device. The pt reported that their depression has gotten worse. It is unk if this is above or below their prevns rate. The pt was seen by a surgeon and they did not feel the vns was causing the pt's pain and that they did not require any kind of surgical revision. They have been referred to see a neurologist. No current device diagnostics have been received to confirm device function. Good faith attempts are underway to investigate the pt's reported events.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2255823
Report Number1644487-2011-01953
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial,Followup,Followup
Report Date 07/27/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/30/2008
Device MODEL Number102
Device LOT Number015644
Was Device Available For Evaluation? No
Date Manufacturer Received11/11/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2006
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: 08/22/2011 Patient Sequence Number: 1
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