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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 01/24/2011
Event Type  Injury  
Event Description

It was reported via clinic notes that a vns pt was having increase in seizures, voice hoarseness, and aspiration. On (b)(6) 2011, the neurologist referred the pt for generator replacement since it was near end of service. The generator was received by the mfr and currently is undergoing product analysis.

 
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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 Key2190784
Report Number1644487-2011-01688
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/08/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2006
Device MODEL Number102
Device LOT Number010960
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/19/2011
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/08/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/01/2004
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: 07/26/2011 Patient Sequence Number: 1
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