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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 01/12/2009
Event Type  Injury  
Event Description

It was reported to manufacturer that the vns patient was hospitalized due to painful stimulation in the neck, chest, and arm in addition to a choking sensation with stimulation. The vns device was disabled and the pain was still present, but the dysphagia resolved. Diagnostic tests were performed following the onset of the events, and were reported to be within normal limits. There was no report of trauma, manipulation or other believed cause prior to the onset of the event. As intervention, the physician opted to have the entire device replaced. The explanted lead and generator were returned to manufacturer and analysis underway. Attempts to obtain additional information in regards to the patient status following revision surgery from the treating physician have been made, but have been unsuccessful to date.

 
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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 Key1310986
Report Number1644487-2009-00273
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/16/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2006
Device MODEL Number102
Device LOT Number11989
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/29/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/16/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/01/2005
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: 02/11/2009 Patient Sequence Number: 1
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