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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 Detachment Of Device Component; Fluid Leak; High impedance
Event Date 01/12/2015
Event Type  Malfunction  
Event Description

It was reported by the physician's office that the patient was referred for a vns consult for an unknown reason and the plan was for vns generator replacement, but a lead replacement may also be needed. No information was initially provided. An implant card was later received showing the patient underwent a full vns revision. The diagnostics for the old device showed high impedance. It was also explained that the lead had visible "holes" and fluid within the silicone tubing. Diagnostics with a new generator and the old lead still showed high impedance. Adequate insertion of the lead pin into the generator was confirmed, but the high impedance did not resolve. The new generator was tested using the resistor pin and confirmed good diagnostics. Upon exposing the electrodes within the neck, it could be seen that one of the electrodes was no longer wrapped around the vagus nerve. Per the anesthesiologist, the patient had been known to have severe falls due to seizure activity and the compromises in the lead may have occurred during one of the falling evens. Once both the lead and the generator were replaced, diagnostics were within normal limits. The explanted generator and lead were reported to be discarded after the surgery.

 
Manufacturer Narrative

This information was inadvertently reported incorrectly on the initial mfr. Report.

 
Event Description

The programming history database was reviewed and no anomalies related to the high impedance was noted. Additional information was received from the patient's following physician stating the reason for the vns replacement referral was due to battery depletion and high impedance. Additionally, the physician did not know the cause of the holes, fluid leaks, or electrode detachment from the nerve.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
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 Key6461922
Report Number1644487-2017-03571
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/05/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2009
Device MODEL Number302-20
Device LOT Number200185
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/26/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/17/2006
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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