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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 03/01/2009
Event Type  Injury  
Event Description

It was reported that the patient was experiencing pain when she turned her head to either side. Patient had her device turned off in 2009 to see if it would resolve the pain. Patient also saw a surgeon who said he will consider surgery if the pain does not resolve with the device turned off. Physician believes the patient's reported events are a result of a fall she had a few months ago, but it is unknown if it is related to vns. No casual or contributory programming or medication changes preceded the onset of the reported events. Attempts for further information have been unsuccessful to date and surgery has not occurred 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 Key1520016
Report Number1644487-2009-02422
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/29/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/29/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2010
Device MODEL Number102
Device LOT Number2098
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/29/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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