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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 08/23/2012
Event Type  Malfunction  
Event Description

X-rays were received on (b)(6) 2012, by the manufacturer, and the radiology report indicated that the patient was experiencing neck pain. Review of the ap and lateral chest and neck x-rays, dated (b)(6) 2012 revealed that the generator can be visualized in the left chest and it appears to be in a normal orientation. The lead pin appears fully inserted into the connector block. The filter feedthru wires appear intact and the lead wires appear intact at the connector pin. The lead wire does not appear to be located behind the generator. The electrodes were visualized in the neck and appear in the proper orientation. There appears to be two partial lead fractures in the chest area above the generator. No additional gross discontinuities or sharp angles in the images provided are visualized. Based on the x-rays received, there are two partial lead fractures present in the chest area which may be contributing to the pain. Follow up with the company representative revealed that the patient's pain was thought to be the same pain the patient experienced before in the neck and shoulder area in 2011 due to generator migration and patient trauma from a car accident (before the physician was aware that there appears to be two partial lead breaks). The physician believed the pain may be related to the generator migration or potentially scar tissue at the electrode site which may be making the strain relief less prominent during neck movement. However now, the pain occurs during stimulation and when she turns her head ot the right or left. The plan is to discuss this with her on the next visit and evaluate if surgery may be needed. The physician suspects that the strain relief may or may not be present anymore due to scar tissue or it may be pulling the lead wire back into the neck area. The physician reported that all diagnostics are within normal limits, and he does not think there is a lead break but only associated with the strain relief. It could have had more of a strain relief and then when the generator migrated, caused a less prominent strain relief. If the pain is still present and it is decided to pursue surgery, the physician and company representative indicated that he would suggest to open up the pocket and neck, move the generator higher in the pocket, capture the lead wire and make a proper loop/strain relief. The physician did not know when the patient will be seen next and does not know how much dysfunction the pain is causing her. The pain does not occur every time during stimulation and is not constant, but only when she turns her neck. The device had not been turned off to date as of (b)(4) 2012. Attempts for additional information have been unsuccessful to date thus far.

 
Event Description

Product analysis on the returned lead assembly was completed. The lead was returned in three portions. The connector pin, connector ring, and lead's electrodes were not returned for evaluation. The reported high impedance and lead discontinuity allegations were not verified within the returned lead portions. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portions.

 
Event Description

Patient reported on (b)(6) 2012 that she is doing well.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

Conclusion, corrected data: the supplemental report #4 inadvertently reported the incorrect conclusion code. No device failure is suspected. No device malfunction is suspected, and the (b)(6) 2012 x-rays did not show a lead fracture, so the event is coded as confirmed invalid. In addition, normal mode and system diagnostics were reportedly within normal limits.

 
Event Description

The return product form indicates that the reason for lead replacement on (b)(6) 2012 was due to lead discontiuity. Product analysis on the explant lead has not been completed to date. The generator was not replaced.

 
Manufacturer Narrative

Device available for evaluation, corrected data:the supplemental report #2 inadvertently did not include the date in which the lead suspect device was received by the manufacturer.

 
Event Description

An implant card was received by the manufacturer on (b)(4) 2012 which revealed that the patient had lead replacement surgery on (b)(6) 2012 due to "lead discontinuity. " the explanted lead was received by the manufacturer on (b)(4) 2012. However, product analysis has not been completed to date.

 
Event Description

Additional information was received indicating that the physician performed both normal mode and system diagnostics which resulted in okay results. They were perplexed because the diagnostics are okay but the x-rays show a partial lead break (which the physician and company representative also observed). A/p and lateral x-ray images of the chest and neck dated (b)(6) 2012 were also received by the manufacturer. The generator placement appears lower than normal in the left chest. Without images from immediately following implant surgery in (b)(6) 2010, it is difficult to assess whether the generator has migrated. The connector pin appears to be fully inserted inside the connector block, and the lead wires appear to be intact at the connector pin. The filter feed-through wires also appear intact. No portion of the lead appears to be located behind the generator. The electrodes were visualized in the neck and appear to be in the proper orientation. Unlike the previous images dated (b)(6) 2012, there do not appear to be any lead fractures in the chest area above the generator. No gross discontinuities or sharp angles are visualized in the images provided. However, a micro-fracture or unpronounced lead discontinuity cannot be ruled. It appears that there was likely an artifact in the images dated (b)(6) 2012 that made it appear as though there were two partial lead fractures in the chest area. Based on the x-ray images provided, no anomalies can be observed to account for the reported pain and potential generator migration. It can be noted that these are adverse events and not device malfunctions, and therefore, they are not expected to be observed on an x-ray. No gross lead discontinuities or sharp angles could be visualized, however an unpronounced lead discontinuity cannot be ruled out. No anomalies were identified that could account for the adverse event. The physician believes inadequate strain relief in the neck may be contributing to the patient's pain in the neck. She only gets the painful stimulation when she turns her head to the right. They believe the generator has migrated which may be pulling on the leads from the two tie-downs due to poor strain relief. The patient has received good efficacy from vns therapy. The physician believes the way to resolve this is to fix the strain relief, however, no interventions have been planned to date. Although surgery is likely, it has not occurred to date.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key2754445
Report Number1644487-2012-02404
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 08/23/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/21/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/16/2014
Device MODEL Number302-20
Device LOT Number2602
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/21/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/14/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/18/2010
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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