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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK Back to Search Results
Event Date 02/26/2009
Event Type  Death  
Event Description

It was reported that a vns patient died three days post implant and prior to the vns device being programmed on. Further information provided by the medical professionals revealed that the patient had several health issues including sickle cell anemia. The patient was implanted in 2009, and left the hospital the following day. Two days later, the patient was transported to the emergency room and died the following day. Information received by a company representative revealed that the patient was turning blue on the way to the emergency room. Moreover, the patient's grandmother did not authorize an autopsy and it is not believed that the vns device was explanted before burial. Further follow up from the treating neurologist revealed that he did not believe that the patient's death was related to vns therapy and an official cause of death has not been determined. The treating neurologist believes that the patient's blood may have sickled and possibly caused the patient's death. The patient reportedly had abnormal blood work prior to the vns implant surgery. Although the patient was not receiving vns therapy at the time of death, the relationship of the death and vns implant surgery is unknown. Good faith attempts to obtain additional information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL UNK
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd, ste 600
houston , TX 77058
2812287200
MDR Report Key1355311
Report Number1644487-2009-00656
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/03/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/03/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 04/02/2009 Patient Sequence Number: 1
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