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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 03/01/2009
Event Type  Injury  
Event Description

It was reported that the vns depression pt was experiencing left arm, left shoulder, left neck and jaw pain with stimulation of the device. The pt was no longer being followed by the psychiatrist, and was referred to a neurologist to assess the painful stimulation. Further follow up with the neurologist who evaluated the pt, revealed that numerous settings were tried, diagnostics were performed to assess the impedance and battery life, in addition to chest and neck x-rays, and multiple neurological tests, and all came back negative per the neurologist. The neurologist subsequently disabled the vns device and the pain resolved. System diagnostic testing performed prior to disabling the device revealed normal device function. Add'l info was received that surgery was planned to have the device explanted. Surgery subsequently occurred and good faith attempts to obtain the explanted devices 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 Key1518834
Report Number1644487-2009-02383
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/25/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2007
Device MODEL Number102
Device LOT Number14675
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/25/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2005
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: 10/23/2009 Patient Sequence Number: 1
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