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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 02/22/2012
Event Type  Malfunction  
Event Description

Additional information was received indicating that the patient's generator has been replaced. An implant card was received that indicated the reason for replacement was "erratic stim. " the explanted generator has been returned and is currently undergoing analysis.

 
Event Description

Analysis of the patient's explanted vns generator has been completed. The generator performed to specifications and no anomalies were found. Review of the generator source code found that the last impedance value taken prior to the generator being disabled was normal at 3029 ohms.

 
Event Description

It was reported by the vns patient that she felt the vns was stimulating erratically and she was experiencing painful stimulation in her neck when she turned her head to the right. The physician took x-rays which were forwarded to the manufacturer for review. Review of the x-rays found no anomalies. No gross lead fractures or sharp angles could be visualized. Vns diagnostics were within normal limits, however no specifics were available. The patient's device was disabled and she stated she was still experiencing the adverse events. No medication or programming changes preceded the onset of the pain. No trauma or manipulation is believed to have occurred. The patient also stated her neck hurts at the electrode site when she lies down. The patient requested to have her device replaced. Follow-up with the site found that the physician is not sure what the events are related to. Surgery to replace the patient's vns is likely.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2511973
Report Number1644487-2012-00867
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/02/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2011
Device MODEL Number103
Device LOT Number2572
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/19/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/25/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/24/2010
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: 03/30/2012 Patient Sequence Number: 1
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