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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 01/01/2007
Event Type  Injury  
Event Description

It was reported via clinic notes received that the vns pt has a "history of intracerebral aneurysm with left mca stroke. " the notes also indicate "conventional cerebral angiography showed no recurrence of aneurysm (b)(6) 2007. " the relationship of this stroke to vns is unk. No device failure is suspected. Attempts for further info from the physician have been unsuccessful to date.

 
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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 Key2372103
Report Number1644487-2011-03033
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/11/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2005
Device MODEL Number102
Device LOT Number009728
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/11/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2003
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: 12/09/2011 Patient Sequence Number: 1
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