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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 03/01/2011
Event Type  Injury  
Event Description

The pt reported that his lead had slipped and is now in a knot. The pt reported that he is able to see the knot in his neck. Also, the pt reported being shocked with stimulation in the neck and ear. The pt saw his physician regarding the issue, and the was told the device "works. " the pt's settings were reportedly decreased on (b)(6) 2011 due to the shocking sensation, which has helped the issue. He had also been sent for x-rays and a surgery consult. Furthermore, the pt stated that prior to the setting decrease, the left side of his head had been numb; he had also been having an increase in seizure activity. The mfr's programming history was searched and the pt's last known settings were on (b)(6) 2010. Diagnostic testing on this date showed normal device function. Later info was rec'd indicating no trauma or manipulation had occurred. Recent diagnostics were stated as being "ok", and the pt was still having less seizures than before vns. No medication changes had been made prior to the increase in seizures. The site also said that there were no medication changes prior to the painful stimulation, but the pt's pulse width and frequency were decreased, and the pt then could tolerate stimulation. The physician indicated that the numbness that the pt had experienced was not related to vns. Attempts for further info have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key2133423
Report Number1644487-2011-01327
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 05/16/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2011
Device MODEL Number102
Device LOT Number2594
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received05/16/2011
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: 06/15/2011 Patient Sequence Number: 1
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