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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 100

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CYBERONICS, INC. PULSE GEN MODEL 100 Back to Search Results
Model Number 100 C
Event Date 09/26/2000
Event Type  Injury  
Event Description

It was reported in a scientific article that a vns patient, who had initially responded to vns therapy, began to experience an "abrupt worsening of her epilepsy" after increasing her therapy output current by 0. 25ma (2. 25ma to 2. 50ma). The author indicated that this worsened seizure activity consisted of an increase in seizure frequency, above pre-vns baseline levels, as well as the development of a new seizure type. The article states that the patient had "no history of recent aed changes or dose omission, protracted sleep deprivation, stressful events, trauma, or intervening infection could be elicited and both the generator and the lead were functioning normally". The author states that once the patient's ncp device was programmed off, "2 days later the new seizure type ceased and the patient's habitual seizures settled down to pre-implantation baseline. " in light of these events, the pt's device was reportedly programmed back on a month later due to the initial efficacy she had received from vns therapy. The pt's output current was gradually increased up to 1. 75ma and after six months of follow up, the patient reportedly regained the efficacy that she had initially obtained with no relapse of the new seizure type.

 
Manufacturer Narrative

Article citation: koutroumanidis, michael, michael j. Hennessy, colin d. Binnie, and charles e. Polkey. "aggravation of partial epilepsy and emergence of new seizure type during treatment with vns. " neurology 55 (2000): 892-93.

 
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Brand NamePULSE GEN MODEL 100
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1400101
Report Number1644487-2009-01145
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 05/28/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number100 C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/28/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/05/2009 Patient Sequence Number: 1
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