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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 02/07/2012
Event Type  Malfunction  
Event Description

It was reported via clinic notes received for review that a vns patient was having seizures on clinic visit date (b)(6) 2012. Reported patient doing ok. Currently off vimpat. Doing about the same, still having some drops and the seizures which last about a minute. The patient gets a little cyanotic with these spells. On visit date (b)(6) 2012 the patient reported that he's been having more seizures. Over the prior 3-4 weeks he had been having more episodes of not breathing for over a minute and can be cyanotic. The patient was going to be referred to their surgeon for follow up. It is unknown the relationship of their seizures to the vns baseline and if this is a new seizure type for the patient. Thus far no further information has been attained.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2775951
Report Number1644487-2012-02549
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/12/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/08/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2008
Device MODEL Number102
Device LOT Number015424
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date09/12/2012
Event Location Other
Date Manufacturer Received09/12/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/09/2006
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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