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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 05/01/2011
Event Type  Malfunction  
Event Description

It was reported that a patient was experiencing pain in his neck and had lost his voice. Diagnostics performed on the patient's generator showed high impedance with a dc/dc of 7. The generator was programmed to 0ma and the patient was sent for x-rays. It is unclear if the x-rays will be sent to the manufacturer for review. The patient has been scheduled to see an ent and has been referred for surgery. Surgery is likely, but has not occurred to date.

 
Event Description

Attempts for additional information have been made to both the patient's treating neurologist and surgeon, and no information has been made available by either site.

 
Event Description

Additional information was received that the patient would have the device explanted and go for a surgical work-up. The nurse indicated that the patient is not likely a surgical candidate, so will have a new vns implanted at a later date. No additional information was provided. Surgery is likely, but has not occurred to date.

 
Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery due to lead discontinuity on (b)(6) 2014. Attempts to have the product returned for analysis were made but were unsuccessful.

 
Event Description

Additional information was received indicating that the patient has declined replacement. His device has since been disabled. Attempts for additional information have been unsuccessful to date.

 
Event Description

The explanted lead and generator were received by the manufacturer for product analysis. Product analysis was completed on the returned portions of the explanted lead. During the visual analysis of a returned 3. 5mm portion of the negative green electrode, it was observed that the coil portion of this segment was not present. What appeared to be a greenish tint was observed inside the inner silicone tubing. This was an indication the coil had most likely dissolved and became detached from the ribbon at one point in time. Stimulation was present for a certain period of time as evidenced by the presence of greenish tint inside the inner silicone tubing. Based on the findings, there was evidence to suggest a discontinuity in the returned portions of the device. With the exception of the discontinuity, the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portion were performed and no other discontinuities were identified. The set screw marks found on the lead connector pin provided evidence that, at one point in time, a good mechanical and electrical connection was present. The returned generator is undergoing product analysis.

 
Event Description

Product analysis of the returned generator was completed. Visual analysis showed only observations consistent with the explant procedure; no surface abnormalities were noted on this device. The pulse generator communicated normally and the eri flag was not set. The device performed according to functional specifications. No abnormal performance or any other type of adverse condition was found.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2229120
Report Number1644487-2011-01869
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2008
Device MODEL Number302-20
Device LOT Number1049
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/20/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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