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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
Event Date 02/01/2012
Event Type  Malfunction  
Event Description

It was reported normal mode and systems diagnostic tests revealed high impedance. The physician's office planned on disabling the device on this day and was referring the patient for x-rays. The patient had a blackout in (b)(6) and feel on his left shoulder. He has had shoulder pain ever since, but has not felt a difference in vns stimulation. This fall may have contributed to the high impedance, per the physician. The last time diagnostics were performed on the patient's device was reportedly a year ago. The patient is likely being referred for generator and lead replacement surgery, but it has not occurred to date. Attempts for additional information have been unsuccessful to date. Film and computer a/p and lateral x-rays images of the neck and chest were reviewed by the manufacturer. It appears that one (or both) electrodes is detached from the nerve, as the positive electrode is angled at approximately a 120 degree angle from the negative electrode. It is unlikely that the patient's nerve curves in such a fashion. It appears that the positive electrode may be detached from the nerve. There were no acute angles or lead discontinuities seen in the visible portion of the lead body. Based on the x-ray images provided, the cause for the reported high impedance is most likely related to the electrode being detached from the nerve. The presence of a microfracture in the lead or a lead discontinuity in the portion of the lead that was behind the generator cannot be ruled out.

 
Event Description

The patient had generator and lead replacement surgery on (b)(6) 2012 due to the high impedance. The explanted products were received by the manufacturer for analysis, however it has not occurred to date. The return product form reported that the generator was replaced prophylactically and the lead was replaced due to the electrode being off of the nerve.

 
Event Description

Clinic notes were received dated (b)(6) 2012, which again reported that the patient blacked out in (b)(6) 2012, fell, and landed on his left shoulder. The patient feels like he pulled the lead at that time. It was also noted that the battery is low. The patient felt that the vns was helping him prior to the device being disabled when the high impedance was first observed at (b)(6). The notes also reported that the x-rays revealed that the lead appears to be off the vagal nerve, which was reported by the manufacturer. The physician is referring the patient for generator and lead replacement surgery. Although surgery is likely, it has not occurred to date.

 
Event Description

Product analysis was completed on the generator and lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 96mm portion the quadfilar coils appeared to be stretched and kinked approximately 72mm and 92mm past the end of the electrode bifurcation. The end of quadfilar coil 1 appeared to be broken approximately 72mm from the end of the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting 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. No other obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.

 
Manufacturer Narrative

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

 
Event Description

The implant card was received and confirmed the generator and lead replacement surgery on (b)(6) 2012. The generator was replaced prophylactically, and the lead was replaced due to the electrode being off the nerve and therefore causing the high impedance. Lead impedance following replacement was okay. Product analysis for the explanted products has not been completed to date.

 
Manufacturer Narrative

Date of event, corrected data: the initial report inadvertently reported the incorrect date. The clinic notes received on (b)(4) 2012, indicated that the patient blacked out in (b)(6) 2012, fell, and landed on his left shoulder. The patient feels like he pulled the lead at that time which likely contributed to the high impedance.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2543658
Report Number1644487-2012-00999
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/29/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/20/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2006
Device MODEL Number302-20
Device LOT Number011608
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/25/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/31/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/15/2004
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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