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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 07/01/2009
Event Type  Injury  
Event Description

It was reported that a patient experienced a series of seizures that were different from her normal seizure type. The physician wondered if maybe the device was not functioning properly regardless of acceptable diagnostics. The patient could not tell whether or not her device was on. The physician did state that it is difficult to tell if these new seizures are new seizure types of if they are pseudoseizures. The patient has been referred for generator revision however, the surgery is on hold.

 
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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 Key1744398
Report Number1644487-2010-01518
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 06/04/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2004
Device MODEL Number102
Device LOT Number6575
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/04/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2002
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: 06/30/2010 Patient Sequence Number: 1
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