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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 01/01/2010
Event Type  Injury  
Event Description

It was reported that the pt had stopped eating after implantation of vns device. The physician does not attribute this change to the vns device. However, they are considering stopping the pt's vns therapy to see if it has any impact. The pt is in a group home, is mentally retarded, and non-verbal. The pt has lost a significant amount of weight and his health is in peril. Clinic notes indicate that there have been times where he had refused to eat in the past. 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 Key1672110
Report Number1644487-2010-01066
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 04/02/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2011
Device MODEL Number103
Device LOT Number201216
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received04/02/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2009
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: 04/30/2010 Patient Sequence Number: 1
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