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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104

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CYBERONICS, INC. PULSE GEN MODEL 104 Back to Search Results
Model Number 104
Event Date 01/01/2010
Event Type  Injury  
Event Description

It was initially reported by a vns patient's mother that the pt was experiencing "a lot of severe gi issues. " the mother clarified by saying she first sought help for the issues in (b)(6) 2010, but the pt had to have his gall bladder removed in (b)(6) 2010 due to gall stones. The pt had now recently developed "severe esophageal erosion", a hiatal hernia, and severe reflux. According to the mother's report, the esophageal erosion was severe enough that a food bolus was lodged in the eroded cavity in the patient's throat. The mother did report that she was pleased with the seizure control from the vns, but she was worried the vns may be causing the gi events. Follow-up with the patient's gastroenterologist was obtained. However, the pt had only been seen at the site twice. The pt had been referred to the site because of nausea, vomiting, and abdominal pain after his gall bladder surgery. The nausea and vomiting were likely related to the patient's surgery, and notes from the patient's neurologist indicated that the pain could not be caused by vns. The gastroenterologist had performed a ct scan on the pt in (b)(6) 2011, which showed a thickening of the bladder wall, but this was not attributed to vns. The gastroenterologist's office stated that the issues of the patient's reflux, gall bladder, hernia and erosion could not be answered by them, but the patient's family practitioner who had referred the pt to them may be able to provide more info. Good faith attempts made to the patient's family practitioner to date for more info on the patient's reflux, gall stones, hernia, and esophageal erosion have been unsuccessful.

 
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Brand NamePULSE GEN MODEL 104
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1972380
Report Number1644487-2011-00111
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 12/29/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/25/2011
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 Number104
Device LOT Number1991
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received12/29/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2008
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: 01/25/2011 Patient Sequence Number: 1
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