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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 08/09/2013
Event Type  Malfunction  
Event Description

A review generators memory data extracted from available patient programming history revealed that a large increase (>25%) in system impedance occurred between (b)(6) 2011 (i. E. 1636 ohms to 4285 ohms), which may signify the onset of the stress inducted fracture observed during an analysis of the patient¿s explanted lead. Additionally, silicone tubing abrasion, which penetrated the inner and outer tubing, were observed on lead body as well as remnants of what appeared to be dry body fluids within these areas.

Manufacturer Narrative

Describe event or problem, corrected data: the supplemental 1 report did not include information regarding the abarded opening in the inner and outer tubing. The information has been included in this report.

Event Description

Follow up with the physician found that they will not provide access to the vns programming system to get a copy of the patient's vns programming history. It was reported that the programming system was working and there were no suspected issues with it. No x-rays were taken or planned to be taken. Product analysis was performed on the explanted lead and verified a break was identified in the negative coil. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location. Appearance of the negative coil suggests a stress-induced fracture has occurred in at least three strands of the quadfilar coil. A conclusive determination of the fracture mechanism on one strand of the quadfilar coil cannot be made due to mechanical distortion (smoothed surfaces). Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description

On (b)(6) 2013, it was reported that the patient was receiving a battery replacement due to end of service. After the battery was removed and a new one connected, diagnostics were performed which showed high impedance. The surgeon made several attempts to remove and reinsert the lead pin to verify it wasn't a lead pin issue. He also made sure that the hex screwdriver was fully inserted when connecting the device; however, diagnostics still showed high impedance. The surgeon elected to replace the lead. Additional information was received that the patient is highly active and frequently agitated, with profound mental retardation. There was no specific manipulation or trauma known related to the high lead impedance. The surgeon examined the lead placement while performing the explant and observed that proper strain relief was present and the electrodes were in correct position. There was no excessive scarring on the vagus nerve noted. Diagnostics performed with the new lead and generator showed no more high lead impedance. Review of the lead and generator device history records confirmed all quality tests were passed prior to distribution. The explanted devices were returned to the manufacturer. Product analysis of the generator indicates high impedance of 8695 ohms (previous recorded impedance value of 6404 ohms) occurred on (b)(6) 2012. Confirmed a battery voltage issue; known electrical design operation caused by a high electrical demand on the circuit requiring >10. 5 output volts; also confirmed a component (c4 - ceramic chip capacitor) that was measured to be out-specification, which could be related to drift; also confirmed an output pulse disabled condition due to a perceived low battery voltage; may be related to high energy exposure during explant process. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. An end-of-service warning message was verified in the pa lab and found to be associated with the pulsedisabled by the pulse generator. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 1. 994 volts, verifying an eos condition. The data in the diagaccumconsumed memory locations revealed that 70. 854% of the battery had been consumed. With the exception for capacitor c4 out of specification, the post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. This is not expected to have an adverse effect on battery longevity. The cause for the out of specification capacitor, c4, (v cpu) value is likely associated with component aging.

Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3330787
Report Number1644487-2013-02610
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/09/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/06/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2004
Device MODEL Number302-20
Device LOT Number6593
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/12/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/03/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/25/2002
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial