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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 08/05/2011
Event Type  Injury  
Event Description

It was reported by the pt that she had experienced an arrhythmia while in the hosp for her vns initial implant. She did not specify what kind of arrhythmia it was but only stated that it "was not there before. " it was not clarified if it occurred during the surgery or post-implant. F/u with the neurologist's office found that the site had not heard of any adverse events and the pt was doing well at the visits following vns implant. Per the site, the pt's vns is functioning normally however specific vns diagnostics were not provided. A staff member at the surgeon's office said she was not aware of any of the events but would confirm with the surgeon. The pt also reported hotness and swelling at the wound site, nausea, visual disturbance, difficulty swallowing, and choking following surgery as well however none of these events were able to be confirmed with the neurologist or surgeon at this time. Attempts for further info 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 Key2249204
Report Number1644487-2011-02119
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 08/09/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/08/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2013
Device MODEL Number103
Device LOT Number3033
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received08/09/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2011
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: 09/08/2011 Patient Sequence Number: 1
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