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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 05/01/2006
Event Type  Injury  
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Brand NamePULSE GEN MODEL 101
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
donnie welty, rn, bsn
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1629932
Report Number1644487-2006-00276
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/03/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/31/2001
Device MODEL Number101
Device LOT Number38588C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/03/2006
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/09/2000
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: 03/12/2010 Patient Sequence Number: 1
Treatment
LAMICTAL 50MG BID
IMPLANTED:
BIPOL LEAD: MODEL 300-20, (B) (4)
CLONAZEPAM 1MG TID
INDERAL 120MG Q AM
DEPAKOTE 2500MG Q DAY
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