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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 05/01/2009
Event Type  Injury  
Event Description

It was reported that the patient was having abdominal cramps, vomiting, nausea and multifactorial abdominal pain. The events were severe in nature. Patient was hospitalized. As per medical professional, patient's abdominal pain was possibly related to implantation, vomiting was possibly related to implantation and stimulation, nausea was possibly related to implantation and stimulation and multifactorial abdominal pain was possibly related to stimulation.

 
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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 Key1431958
Report Number1644487-2009-01660
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/07/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2010
Device MODEL Number102
Device LOT Number2214
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/07/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2008
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: 08/06/2009 Patient Sequence Number: 1
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