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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problems Leak / Splash; Positioning Problem
Event Date 11/08/2014
Event Type  Malfunction  
Manufacturer Narrative

Event Description

It was reported that the vns patient underwent explant surgery on (b)(6) 2015 due to lack of efficacy. It was noted that the patient was developmental delayed and was hitting himself in the chest. The explanted generator and lead were returned to the manufacturer for analysis. Analysis of the lead identified that the connector pin had evidence of pitting and electro-etching on the surface. It was also found that the lead had not been fully inserted into the cavity of the generator. Lead discontinuity was found in both positive and negative quadfilar coils in the body region of the returned lead portions. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on (b)(6) 2014, where the impedance value changed from high lead impedance to a normal limits range. Complete analysis of the generator was reported in manufacturer report # 1644487-2015-05615.

Event Description

Follow-up was performed with the patient's neurologist. He was informed that product analysis found lead fractures and high impedance. He was not aware of any high impedance. System diagnostics were always within normal limits to his knowledge. The patient's mother was adamant that the device was not helping, but he did not agree. He programmed the device off in (b)(6) 2014 and left the magnet on. At that time the impedance was 3980 ohms. The patient had a lower seizure frequency about a year after implant. He disabled the device in (b)(6) 2014 to prepare for explant in 2015 as requested by the patient's mother. His protocol is to leave the device off for 6 months to determine whether vns is actually helping the patient. Within 6 months of disabling the device, the patient started to experience drop seizures, which he has never had before. The neurologist maintained that vns was clearly helping the patient as the patient did not have a new seizure type in 14 years until vns was programmed off. He did not think the patient hitting himself was in any way related to the high impedance which was found, as the patient was hitting himself as soon as the device was implanted.

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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
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 Key5029418
Report Number1644487-2015-05614
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 07/28/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/23/2016
Device MODEL Number304-20
Device LOT Number3316
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/01/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/11/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/24/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial