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

Model Number 304-20

Device Problems Leak/Splash (1354); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 11/08/2014

Event Type  malfunction  

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.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• 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 Key: 5029418
• MDR Text Key: 25010535
• Report Number: 1644487-2015-05614
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/23/2016
• Device Model Number: 304-20
• Device Lot Number: 3316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR