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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 102
Event Date 04/08/2009
Event Type  Injury  
Event Description

It was reported that a vns patient was experiencing "severe issues with stomach ulcerations" and that the issue resolved with device disablement. Follow up with the patient's treating vns therapy, physician revealed that the patient had complained of an abdominal discomfort eight months prior to this initial report and that a endoscope performed earlier in this year had revealed the presence of several "brown spot and ulcerations". The physician indicated that there had not been any changes to patient therapy settings or medications prior to the onset of the abdominal discomfort and that the event began to improve with a decrease in therapy settings. Recent device diagnostic reportedly confirmed proper device function. The physician opted to disable the patient's device which reportedly resulted in "a cessation of abdominal pain. ".

 
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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 Key1415218
Report Number1644487-2009-01513
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/18/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2004
Device MODEL Number102
Device LOT Number7732
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/18/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2003
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: 07/16/2009 Patient Sequence Number: 1
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