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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 01/01/2005
Event Type  Injury  
Event Description

It was reported in a scientific article that a vns patient was explanted for the third time of vns therapy due to recurrent skin breakdown and infections at the chest generator site. After removal of the vns therapy system, the patient showed no clinical evidence of damage to the left vagus nerve and was re-implanted on the right side due to the recurring infections.

 
Manufacturer Narrative

Article citation: mcgregor, amy, james wheless, james baumgartner, and david bettis. "right-sided vagus nerve stimulation as a treatment for refractory epilepsy in humans. " epilepsia 46 (2005): 91-96. Print.

 
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Brand NamePULSE GEN MODEL 101
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer (Section G)
.
Manufacturer Contact
nydia grimes
100 cyberonics blvd
ste 600
houston , TX 77058
2812287200
MDR Report Key1586197
Report Number1644487-2010-00171
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/23/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/21/2001
Device MODEL Number101
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/23/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2000
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: 01/22/2010 Patient Sequence Number: 1
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