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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Fluid Leak
Event Date 08/26/2012
Event Type  Malfunction  
Event Description

Additional information was received on (b)(6) 2012 indicating that the revision surgery had resolved the pain issues. Additionally a review of the device manufacturing records indicated that the lead had passed all functional and electrical tests, as well as all quality inspections prior to distribution. A user facility report; number: (b)(4), was also received. This reported that the patient was experiencing "electric like shock above the stimulator and over the pectoral region". During revision, fluid was observed inside the lead insulation. The generator was tested during the procedure and was found to be functioning properly. No additional information has been made available.

 
Event Description

It was reported by the patient's physician that the patient had been experiencing some adverse events associated with stimulation. The events started on (b)(6) 2012 and were described as a shocking pain, at the collar bone, which did not occur with every stimulation cycle. Additionally, the patient reported that she could see the lead pulsating during the stimulation. The patient was swollen all the way along the leads from the generator to the electrodes. The device was checked on (b)(6) 2012 and the diagnostics results were all normal and within normal limits. There was no reported trauma. It was reported that when the pulse width was lowered from 500usec to 250usec, the swelling went way within 15 minutes. X-rays were performed and the device was left enabled as the patient could tolerate the events and was doing well with vns therapy. Ap and lateral views of the neck and chest for patient were reviewed. The generator is seen in the left chest area. The filter feedthru wires appear intact and the lead pin can be seen past the second connector block indicating that it is fully inserted into the generator. A portion of the lead appears to be behind the generator. The electrodes were observed in the neck and appear to be in proper alignment. The lead is seen routed down toward the generator. No lead breaks or fractures were observed. Based on the x-ray images provided, it appears that the generator and lead were implanted per labeling guidelines and no fractures or discontinuities are present. The cause of the reported issues could not be identified. Clinic notes were later received for this patient which indicated that the patient was also experiencing increased hoarseness with stimulation and protrusion of the lead. The swelling was said to noticeable and cause redness of the area. Additionally, the patient indicated that she was experiencing muscle spasms with stimulation as well. Following the decrease in settings, the muscle spasms and electrical shocks continued to a lesser degree and the patient also started experiencing an increase in seizures thought to be related to the lowered settings. On (b)(6) 2012, the pulse width was increased again to 500usec, and these settings were tolerated without issue for an hour. On (b)(6) 2012 the patient reported that she continued to have daily "shocking sensations" and "fluttering sensations" in the neck and near her armpit. These were said to be not severe. Additionally the patient reported that she is not performing any particular movements or actions when these feelings are occurring as it can happen when she is not moving and at rest. On (b)(6) 2012 the patient again reported daily electrical shocks with the shocking occurring 4 times on (b)(6) 2012. Additionally she reports neck swelling but indicated that she would not disable the device as therapy has been working for the patient. The patient was seen again on (b)(6) 2012. She reported that her shocking is dally and she can have up to 2 of the "shocking symptoms that startle her and make her jump" otherwise does feel the fluttering (feels electrical flutter) and pain with stimulation along the lead wires just under left collar bone. If she has those shocks, her neck swells and then it becomes red, then it goes into a chest pain/pressure. Diagnostics performed on that date were still within normal limits. While the patient indicated that there had been no manipulation or trauma, her husband indicated that there was pain in her chest caused by their dogs jumping on her. The patient was referred for revision and underwent a lead replacement procedure on (b)(6) 2012. It was reported by the patient's neurologist that, during the procedure, the surgeon identified small pin holes in the lead and bodily fluid inside the insulation. Attempts for product return have been unsuccessful to date as the hospital indicated that they do not have anything to return.

 
Event Description

The patient reported that the surgeon informed her that the lead had fluid in it when it was explanted which he believed caused her pain.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all quality and functional testing 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 304
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 Key2824925
Report Number1644487-2012-02926
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/11/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2015
Device MODEL Number304-20
Device LOT Number3194
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date10/31/2012
Device Age207 dy
Event Location Hospital
Date Manufacturer Received03/12/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/08/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/08/2012 Patient Sequence Number: 1
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