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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 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported by the physician in 2009, that the patient has been hearing voices and hallucinating for about six months, which she feels the patient now needs psychiatric treatment. The physician noted that just prior to the onset of the hallucinations, the patient's device was increased from 1. 75 ma to 2. 0 ma output current. The physician indicated that there have been no known medication changes, but is now on medication for the hallucinations. It was also noted that the patient is experiencing outside stressors, but it is unknown if they are contributing to her recent hallucinations. The physician said she is unsure if the hallucinations are related to the vns therapy, but she does not want to disable the device since the patient is doing well with seizure control. It is unknown at this time what the relationship of the hallucinations is to that of the device and therapy. There is no suspected device failure at this time.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section F)
CYBERONICS, INC.
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key1438288
MDR Report Key1375271
Event Key1039421
Report Number1644487-2009-00916
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/07/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/05/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date06/30/2008
Device MODEL Number102
Device LOT Number015790
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received04/07/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

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