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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 06/18/2009
Event Type  Injury  
Event Description

It was reported by a physician that a vns pt had carotid occlusion after vns surgery which lead to stroke. The physician believed that stroke was related to vns surgery. Pt was referred to rehab and is currently tolerating vns therapy well. There was no device failure associated with the newly implanted device per physician.

 
Manufacturer Narrative

Review of programming/device diagnostic history.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key2149638
Report Number1644487-2011-01449
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 06/27/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/21/2011
Device MODEL Number103
Device LOT Number2300
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/27/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2009
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: 06/29/2011 Patient Sequence Number: 1
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