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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 01/01/2003
Event Type  Malfunction  
Event Description

It was reported to the mfr that the vns pt has been experiencing an increase in seizure activity. It is unk if the increase is above pre-vns baseline. The pt's generator (102r) was believed to be at the end of service, therefore, the pt was sent for generator replacement surgery. During surgery, the new generator was attached to the existing lead body and diagnostic tests were performed that resulted in high lead impedance. Troubleshooting did not resolve the event; therefore, a full revision was performed. During the explant of the existing lead body, it was found that the negative electrode was off the nerve and encapsulated in scar tissue. The positive electrode and the anchor tether remained on the nerve. X-rays were not taken prior to surgery to assess the integrity of the device as an issue with the lead was not suspected. Review of programming history revealed that the pt's previous generator (100c) showed high lead impedance with the same lead body in 2003. Diagnostic tests following that date or test results from generator revision surgery are not available to confirm the resolution of the high lead impedance event. Therefore, the cause of the increase in seizure activity is unk at this time. Good faith attempts to obtain the explanted products back for analysis and add'l info regarding the reported event are underway.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

 
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Brand NameBIPOL LEAD MODEL 300
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1659943
Report Number1644487-2010-00847
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/08/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2000
Device MODEL Number300-20
Device LOT Number33130C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/08/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2000
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: 04/07/2010 Patient Sequence Number: 1
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