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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOLAR LEAD

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CYBERONICS, INC. BIPOLAR LEAD Back to Search Results
Model Number 303-20
Event Date 09/15/2013
Event Type  Injury  
Event Description

It was reported that the patient presented to the emergency room on (b)(6) 2013 with redness at the incision site and was sent home. The following day the neck incision opened up and the patient was seen by the surgeon's pa on (b)(6) 2013 and was sent to the emergency room to have the wound closed with suture and the patient was sent home. It was reported that the wound again opened up on (b)(6) 2013 and the patient was admitted to the hospital and infection was noted. The patient underwent vns system explant on (b)(6) 2013. It was reported that there was pus up into the lead in the neck and chest area. Cultures were taken; however, the results were not yet available. It was reported that the infection was believed to be due to the patient picking at the incision site. Reimplant is likely, but has not occurred to date. The lead and generator were returned on (b)(6) 2013. The generator analysis was completed on (b)(6) 2013. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The lead analysis was completed on (b)(6) 2013. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead assembly were performed with no discontinuities identified. Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications. There is no evidence to suggest an anomaly with the returned portion of the device.

 
Event Description

Clinic notes dated (b)(6) 2013, 17 days post vns implant, indicate the patient's seizures had decreased slightly, there was less postictal effect, the patient was more alert, and the magnet worked to stop a seizure. However, the notes state that the operation site over the unit was puffy, but not red, warm, or tender. The patient had a very low grade fever that started five days ago. The site was swollen and tender to touch. The low grade temperature was 99 to 100 degrees. No redness or drainage was noted. At this time, the physician did not think there was a wound infection and did not start the patient on antibiotics. The patient's medication and vns settings were changed. The device was removed on (b)(6) 2013. Per the notes, the patient was having about five seizures per week. They usually occured right after he falls asleep or awakens. Bilateral arms and legs pull up and stiffen, lasting 15 to 30 seconds. Clinic notes dated (b)(6) 2013 were received which indicate the patient's vns device was removed due to the infection. The notes state that the patient would be re-evaluated the next month for having the device replaced.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

Additional information was received stating that the vns patient was re-implanted with a new generator and lead on (b)(6) 2014.

 
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Brand NameBIPOLAR LEAD
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3414426
Report Number1644487-2013-03239
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/19/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2017
Device MODEL Number303-20
Device LOT Number202399
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/23/2013
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received02/03/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/11/2013
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: 10/16/2013 Patient Sequence Number: 1
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