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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 10/01/2009
Event Type  Injury  
Event Description

Reporter indicated a vns therapy patient had trouble breathing post initial implant surgery, but prior to device stimulation was activated. The patient went to the e. R. , and was diagnosed with pulmonary embolism. The treating physician stated the event was not related to vns, as every surgery has a chance for a patient to have a pulmonary embolism. The patient is on coumadin now, and vns stimulation has not been activated to date. Good faith attempts to obtain additional information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1530569
Report Number1644487-2009-02561
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/15/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2011
Device MODEL Number103
Device LOT Number2419
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/15/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2009
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: 11/13/2009 Patient Sequence Number: 1
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