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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103

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CYBERONICS INC PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 07/01/2010
Event Type  Injury  
Event Description

The vns patient recently had surgery to replace the vns device in (b)(6) 2010 (previously reported in manufacturer report # 1644487-2010-01171), and since surgery, the patient had been experiencing pain in the left neck and the face. The physician had lowered the device settings to help with the pain. Over the next week the pain had resolved and the patient was doing well. It was then reported that the patient began experiencing intermittent seizure activity and confusion on (b)(6) and went to the emergency room. The patient was transferred to a different hospital, and the physician had made minor adjustments to the vns settings, and she was observed for several days but became very ataxic. After the physician's reviewed, the patient's medication, it was noted that the patient had taken an older (expired) bottle of lyrica to the hospital and was receiving twice the prescribed amount. After realizing the issue with the medication, it was corrected and the ataxia resolved and the patient was discharged. The patient was then for a follow up appointment at (b)(6) and the patient was experiencing migraine headaches, which per the physician is usually a sign of latent seizure activity. The physician opted to increase the device settings. Several days later, the patient then experienced a fairly severe migraine with confusion for the majority of the day, which seemed to resolve with no interventions. The patient is being closely monitored by the physician. At the time the patient was experiencing the migraines and confusion, it was also noted that the patient has not had a bowel movement for approximately a week, and the patient's appetite was diminished. The physician additionally explained that the patient is under a great deal of stress in her life at the moment, which could also be a contributory factor. At this time, the physician's assessment regarding the relationship of the events to vns is unclear. Good faith attempts to obtain additional information from the treating physician are currently underway.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1828271
Report Number1644487-2010-02001
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/03/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2011
Device MODEL Number103
Device LOT Number2597
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/03/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2010
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: 09/02/2010 Patient Sequence Number: 1
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