MAUDE Adverse Event Report: CYBERONICS, INC.; LEAD

Device Problems Fracture (1260); Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Describe event or problem; corrected data: the information was inadvertently left off of the supplemental #03 mfr.Report.

Event Description

Only one patient involved in the article was reported in this mfr.Report.The 5 remaining patients have been reported in the following mfr.Report #s: 1644487-2012-00030, 1644487-2012-00043, 1644487-2016-02430, 1644487-2016-02432, 1644487-2016-02431.

Event Description

An article was found which contained information regarding the in situ repair of the vns lead product for 6 patients.It was noted that 5 of the 6 patients had low impedance values pre-operatively, and the 6th patient had normal impedance, but was found during the course of an elective generator replacement to have fractured electrode insulation.It was noted that where the lead insulation was noted to be compromised, it was irrigated with antibiotic-containing solution and dried with a gauze sponge.An appropriate length of silastic tubing that was sufficient to cover the damaged outer sheath with an additional 1-2 cm of tubing extending beyond the damage on either side was then cut.A fresh no.11 surgical scalpel was used to make a lengthwise cut down one side of the catheter tubing, opening the catheter so it could be slipped over the damaged area.The cut catheter was then delicately placed around the damaged sheath and secured at multiple points with circumferential 2-0 silk ties until there was no longer a bend in the lead or exposed inner electrode wires.Cyanoacrylate glue was then introduced into the open side of the cut catheter as a sealant in and around the damaged external insulation, up to either end of the repair.The glue was then allowed to fully dry.At this point, the repaired segment was handled in a similar fashion to the undamaged wiring and reimplanted.It was noted that one patient had some internal wiring exposed.For this patient, the physician performed the same steps for the internal wiring and then performed the steps again for the external wiring.Follow up for the patients ranged from 12 to 87 months.All 6 patients have maintained unchanged seizures control.Two of the patients have since undergone generator replacement surgery due to end of vns generator battery life.Both of the patients remain with the original repaired leads and unchanged appropriate lead impedance.A search of the manufacturer's internal databases was able to confirm that 2 of the patients within the article have already been reported under mfr.Report # 1644487-2012-00030 and mfr.Report # 1644487-2012-00043.Since only initials, sex, and age of the patient at the time of surgery were provided in the article, it was unable to be determined whether the remainder of the patients' low impedance and subsequent surgeries had previously been reported to the manufacturer by the physicians.Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

This information was inadvertently left off of the initial mfr.Report.

Event Description

The patient represented within this mfr.Report is consistent with the patient represented by case # 1 within the article.The patient represented within mfr.Report 1644487-2012-00043 is consistent with the patient represented in the article by case #2.The patient represented within mfr.Report 1644487-2012-00030 is consistent with the patient represented in the article by case #4.The patient represented within mfr.Report 1644487-2016-02431 is consistent with the patient represented in the article by case #3.The patient represented within mfr.Report 1644487-2016-02432 is consistent with the patient represented in the article by case #5.The patient represented within mfr.Report 1644487-2016-02430 is consistent with the patient represented in the article by case #6.

Event Description

This patient's reason for revision was noted to be due to increased seizures and presumed battery death.The patient's lead was found to have a frayed outer sheath during the replacement surgery.The frayed outer sheath is what appears to have initiated the surgeon's repair of the lead.

• Brand Name: NI
• 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: 6046497
• MDR Text Key: 58479569
• Report Number: 1644487-2016-02421
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/25/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/21/2016; 11/18/2016; 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 17 YR