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CYBERONICS INC LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 07/29/2011
Event Type  Malfunction  
Event Description

Reporter indicated the painful stimulation was felt to be related to a "short-circuit" of the vns. X-rays were taken but were not forwarded to the manufacturer. The high lead impedance was first noted on (b)(6) 2011, and the patient had reported feeling electrical shock sensations in her neck when turning her head to the left for the previous month. Vns diagnostics were last within normal limits in (b)(6) 2010. Analysis of the explanted vns generator and lead was completed. No anomalies were identified with the vns generator and the generator performed per specifications. During the lead visual analysis of the returned 35mm lead portion, the green (-) electrode quadfilar coil appeared to be broken approximately 12mm from the distal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged and pitted which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

Manufacturer Narrative

Date of event, corrected data: the correct event date for the high lead impedance is provided. Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description

Reporter indicated a patient was noted to have high lead impedance with vns diagnostics in (b)(6) 2011. The patient was also experiencing painful vns stimulation in her shoulder. The vns was disabled, but no other interventions were done as the patient was pregnant at the time. The patient does have a history of falling with her seizures. The patient delivered her baby in (b)(6) 2012 and surgical replacement of the vns lead and generator occurred on (b)(6) 2012. Diagnostics with the new generator and resident lead still indicated high lead impedance, ruling out a lead pin issue and making a lead fracture more likely. Diagnostics with the new lead and new generator were within normal limits. However, during explant of the resident lead, the jugular vein was nicked which required a vascular surgeon to assist with the repair. The new vns system was left disabled. The explanted generator and lead have been returned and are pending analysis. Attempts for further information are in progress.

Manufacturer Narrative

Device failure is suspected.

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Brand NameLEAD MODEL 302
Type of DeviceLEAD MODEL 302
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2513252
Report Number1644487-2012-00874
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/05/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2006
Device MODEL Number302-20
Device LOT Number11003
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/15/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/05/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/24/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 04/02/2012 Patient Sequence Number: 1