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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture; Mechanical Problem
Event Date 10/23/2017
Event Type  Malfunction  
Event Description

It was reported that the patient was referred for vns generator replacement due to battery depletion. Diagnostics on the form received indicated that the patient's vns was at a near end of service, or neos, = no condition and high impedance was observed with system diagnostics, but not with normal diagnostics. Clinic notes were later received indicating that the patient was experiencing more auras and had become more depressed. The diagnostics provided in the clinic notes indicated the dcdc codes on the previous form received may have been reversed and the system diagnostic were within normal limits. However, the patient underwent full vns replacement surgery and during surgery, high lead impedance was observed. The surgeon found the vns lead to be frayed and the lead separated while being manipulated by the surgeon. It was stated that during testing prior to surgery the dcdc code was within normal limits. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.

 
Event Description

Follow up with the patient's physician revealed that the increase in depression was above the patient's pre-vns baseline per the patient's history. The explanted vns generator and lead were received by the manufacturer. Generator product analysis was completed. The generator was placed in a simulated body temperature environment and the output signal was monitored for more than 24 hours. No signs of variation in the signal were observed. The device performed according to functional specifications. Diagnostics were as expected. Proper functionality of the generator was confirmed. "as received," the generator communicated normally and no battery status indicator was set. No performance or other adverse condition was found with the pulse generator. The vns lead is still pending product analysis.

 
Event Description

Lead product analysis was completed. The reported fracture of leads and abraded insulation was verified in the product analysis, or pa, lab. The lead was returned in six portions. Abraded openings were observed on the outer and inner silicone tubing. A break was identified in both the positive and negative lead coils. Scanning electron microscopy, or sem, images showed what appeared to be wear on the coil strands, which resulted in reduction of the coil's width to point of breaking. Sem identified pitting at the break on the positive coil. A portion of the negative coil was not returned and analysis could not be made as to that portion of the lead. The identified fractures may have contributed to the change in seizure pattern and stimulation not perceived. No other discontinuities were identified within the returned lead portion. Two sets of set-screw marks were identified on the connector pin, indicating that a good mechanical and electrical connection was present at one point in time. The outer and inner silicone tubing of the lead was abraded open at approximately 6. 6-7. 2 cm from the connector boot. The outer silicone tubing was abraded open at approximately 7-8 cm, 18. 8 cm, and 30. 4-30. 6 cm from the connector boot. The inner tubing, which was intact, was protruding from the outer tubing approximately 30. 4-30. 6 cm from the connector boot and forming a loop. The inner silicone of the tubing of the lead coils had abraded openings in the vicinity of the coil breaks. The lead assembly has what appears to be remnants of dried body fluids inside the inner and outer silicone tubing with no obvious point of entry other than the identified tubing openings and the ends of the returned lead portions. Other than the mentioned observations and typical wear/explant related observations, no other anomalies were noted in the returned lead portions.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7105551
Report Number1644487-2017-04974
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/11/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2014
Device MODEL Number302-20
Device LOT Number2658
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/14/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/15/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/05/2010
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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