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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN 102

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CYBERONICS, INC. PULSE GEN 102 Back to Search Results
Model Number 102
Event Date 02/16/2010
Event Type  Injury  
Event Description

Summary: it was reported that a vns patient experienced pain due to unknown reason. Furthermore, the treating psychiatrist indicated the patient was likely experiencing pain due to short circuit as the physician had received a safety alert letter regarding the issue. A review of the patient's programming history revealed the patient's dc dc code at implant was 1 and impedance was ok, but no additional diagnostics were available. Additional information was received through a company representative indicating the patient was seen by a vascular surgeon as the word vns was misinterpreted and confused for varicose veins. The vascular surgeon was not familiar with vns, but stated the patient was experiencing an increase in depression. At the moment it is unknown if the patient's depression has increased as good faith attempts to obtain additional information with the treating psychiatrist have been unsuccessful to date. Furthermore, no device anomalies are suspected at the time as there is not enough information to confirm the event of short circuit.

 
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Brand NamePULSE GEN 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1635355
Report Number1644487-2010-00670
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/16/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/18/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/16/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/18/2010 Patient Sequence Number: 1
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