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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 1002
Event Date 07/01/2011
Event Type  Injury  
Event Description

Reporter indicated that she began having some "heart related issues", where it feels like her heart is skipping beats, and her blood pressure drops, which started occurring about 6 months ago. The reporter questioned if this may be related to her vns device. Attempts for additional information from the treating neurologist have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058 201
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key2423087
Report Number1644487-2012-00135
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 01/04/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/18/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/31/2008
Device MODEL Number1002
Device LOT Number015168
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/04/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2006
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: 01/18/2012 Patient Sequence Number: 1
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