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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 03/28/2000
Event Type  Injury  
Event Description

Reporter indicated via a published article that a vns pt developed horner syndrome as a result of an initial vns implant surgery. The pt had a spontaneous recovery 4 weeks later. The authors concluded that pts implanted with vns should be observed postoperatively for horner syndrome. The authors concluded that the horner syndrome in this pt was likely transient dysfunction of third-order oculosympathetic fibers within the carotid sheath. The pt later underwent prophylactic generator replacement surgery in 2007 for generator near end of service.

 
Manufacturer Narrative

Article citation: american journal of ophthalmology, march 2001; pp 383-384, horner syndrome associated with implantation of a vagus nerve stimulator. Kim, w, clancy, rr, and liu, gt. See scanned pages.

 
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Brand NamePULSE GEN MODEL 101
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1327980
Report Number1644487-2009-00377
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/12/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2001
Device MODEL Number101
Device LOT Number33883C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/12/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2000
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: 02/26/2009 Patient Sequence Number: 1
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