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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC. PULSE GEN MODEL 101

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CYBERONICS INC. PULSE GEN MODEL 101 Back to Search Results
Model Number 101
Event Date 04/27/2010
Event Type  Injury  
Event Description

Clinic notes for this pt were received which documented a new seizure type of an unspecified cause. There was note that there was suspicion of psychogenic non-epileptic seizures (pnes), however, the physician requested an ambulatory eeg be performed as soon as possible in order to characterize the seizure type. It was noted that the pt was scheduled for generator replacement surgery, which took place on may 27th to prophylactically replace the device. The explanted generator has been returned to mfr where analysis is underway. Good faith attempts to obtain additional info regarding the new seizure type and the believed relationship to vns therapy have been made, but no additional info has been received to date. Diagnostic testing done one month prior to the report of the new seizure type revealed normal device function.

 
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Brand NamePULSE GEN MODEL 101
Manufacturer (Section D)
CYBERONICS INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key1739603
Report Number1644487-2010-01486
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/25/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2003
Device MODEL Number101
Device LOT Number7090
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer06/10/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/25/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/2002
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: 06/24/2010 Patient Sequence Number: 1
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