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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
Device Problem Insufficient Information
Event Date 10/01/2009
Event Type  Malfunction  
Event Description

Summary: it was reported that a vns pt was experiencing pain and burning sensation on the generator area along with a tingling feeling in the left neck and ear area. Further info from the treating neurologist indicated that the events were occurring during stimulation and the pt had to go to the er because the pain was so bad. No mentioned interventions were taken at the er other than x-rays and ct scan. Further info from the pt indicated that turning the device off using the magnet ameliorated the reported events. Current system diagnostics provided by the neurologist were ok/ok/3400/ 10 years and both normal and magnet diagnostics were ok. Furthermore, the pt reported a choking sensation when doing a magnet swipe which due to the magnet settings running at higher output and also the fact that the on time is 60 seconds rather than 30 seconds. Furthermore, it was also noticed that the pt had voice alteration issues as current settings were 2/15/130/30/3. At the moment, no pt manipulation or trauma has been reported that could have had contributed to the reported events and no device anomalies are noted as the device is functioning as intended. Further recommendations were made from a company representative to have the device turned off and allow rest to the pt and then program the pt back to intended settings. The recommendation was taken by the neurologist and the pt was programmed off. A week later, the pt was reprogrammed to low setting of. 25 ma but the pt could not tolerate the settings. Interventions were to have the generator and lead replaced due to a suspected malfunction with the devices from the neurologist. Additional info was received in the form of clinic notes from the treating neurologist. A review of the received notes revealed the pt was experiencing the following adverse events prior to having vns explanted. Furthermore, a note was made indicating the pt felt discomfort once the device was re-activated by the neurologist in less than 5 minutes and was recommended vns re-implant due current vns device "not right. " info was received from the treating nurse indicating the reported events of burning sensation, pain in the neck, jaw, left ear, and tingling sensations were related to vns stimulation and the neurologist believe something was wrong with the vns device. The pt's generator was explanted due to painful stimulation and at the moment, good faith attempts to obtain product return have been unsuccessful to date.

 
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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 Key1553673
Report Number1644487-2009-02556
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/16/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2009
Device MODEL Number103
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/16/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2007
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: 11/13/2009 Patient Sequence Number: 1
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