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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 05/01/2009
Event Type  Injury  
Event Description

It was reported that the patient has recently had apneic spells lasting a few seconds each. One woke him up out of sleep and others occurred while he was awake. Patient has history of pulmonary embolisms, but lungs are currently clear. Attempts for further 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 Key1397395
Report Number1644487-2009-01124
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/08/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/02/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2009
Device MODEL Number103
Device LOT Number200905
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/08/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2008
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: 06/02/2009 Patient Sequence Number: 1
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