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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304-20

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CYBERONICS, INC. LEAD MODEL 304-20 Back to Search Results
Model Number 304-20
Event Date 04/26/2013
Event Type  Malfunction  
Event Description

Clinic notes dated (b)(6) 2013 were received which provide the patient's settings that are indicative of high impedance. The cover letter of these notes indicate the patient has had an increase in seizures. A review of the manufacturing records for the lead confirmed that the lead met all final testing specifications prior to distribution. Ap and lateral x-ray images of the neck and chest dated (b)(6) 2013 were received and reviewed. The generator was seen in normal orientation within the left chest area. The filter feed thru wires were intact. It could not be assessed if the lead was intact at the connector pin. The lead pin could not be seen past the connector block; however, it cannot be confirmed if the lead pin is fully inserted due to the angle of the generator in the image. A break was observed in the lead body beyond the anchor tether and negative electrode in the lead. Small pieces of lead were visualized in the neck area near the two tie-downs. There was no strain relief present as there was no lead beyond the anchor tether. The lead appeared twisted and coiled in spirals near the generator at the connector pin, indicative of patient manipulation or trauma. 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. Based on the x-ray images provided, the cause of the high impedance is likely the observed lead break identified in the lead body. Although the x-ray images were indicative of patient manipulation, follow up found that the patient's mother denied any patient manipulation or trauma. It was also stated that the patient has had diagnostic results performed three times since the implant surgery with normal results, so the lead pin must have been inserted into the generator at least initially. The patient's mother additionally reported that the patient has started having nausea and vomiting. It was unknown if the nausea and vomiting are related to vns, so the patient was referred for evaluation on gallbladder issues and lab work. The physician also increased the patient's keppra due to the reported increased seizures. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Event Description

The explant facility does not return explanted devices, therefore, the product will not be returned and product analysis cannot be performed. Follow up with the physician confirmed that the patient had manipulated the device as seen on x-rays and in the explant surgery. The device was disabled on (b)(6) 2013. The patient's mother initially did not believe that the patient had manipulative behavior, but she believed it after the surgeon showed her pictures from the surgery. The nausea, vomiting and decreased appetite may have been unrelated to vns or related to the manipulative behavior for attention, but it is unclear. The increased seizures were at pre-vns baseline and were believed to be related to the lead fracture. After the device was turned off, the seizures decreased again. No additional information was available.

Event Description

Clinic notes dated (b)(6) 2013 indicate that the patient¿s mother reports that since the placement of the vns device in february, the patient has refractory nausea and vomiting, and is unable to eat without subsequent weight loss. In fact, seizure frequency has also increased. The patient¿s mother requested removal of the entire vns system. Other sources for the nausea and vomiting symptoms were searched; however, a gallbladder and upper gi workup were negative and all symptoms coincided with the placement of this device. Per the notes, the physician agreed to the removal, as there is apparently an abnormality at the leads relative to the generator ¿ possibly a loose connection. The patient¿s device was explanted on (b)(4)2013. Pictures of the explanted device during surgery and x-ray images indicate the patient has manipulated the device, as the lead was coiled. No additional information has been provided.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death.

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Brand NameLEAD MODEL 304-20
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 Key3129675
Report Number1644487-2013-01586
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/26/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2016
Device MODEL Number304-20
Device LOT Number202249
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/05/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 05/24/2013 Patient Sequence Number: 1