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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 103
Event Date 11/12/2010
Event Type  Injury  
Event Description

It was reported by a pt through a company representative that since vns surgery, she has been having head and neck pain. The pt was admitted to the hospital and was treated for pneumonia. The pt was then released with oxygen saturation in the 80s according to the patient's sister. At the moment, the patient's device remains off and good faith attempts to obtain additional info 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
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1936140
Report Number1644487-2010-02785
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/12/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2012
Device MODEL Number103
Device LOT Number2779
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/12/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2010
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: 12/13/2010 Patient Sequence Number: 1
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