MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL UNKNOWN

Device Problems Fluid/Blood Leak (1250); Fracture (1260); High impedance (1291)

Patient Problems Pain (1994); Seizures (2063)

Event Date 11/18/2016

Event Type  malfunction  

Event Description

An article entitled "vagus nerve stimulation removal or replacement involving the lead and the electrode: surgical technique, institutional experience and outcome" was sent to the manufacturer and reviewed.During review of the article, multiple reportable events were identified.The article stated that 6 patients had replacement surgeries due to broken wires (lead fractures), and 5 patients had lead surgery due to degradation of the silicone tubing causing high impedance.Of these events, 3 lead fractures and 2 cases of tubing degradation were unable to be identified as previously reported.The patients who had high impedance and lead fractures also reportedly had an increase in seizures due to the device issue.One of the patients who had a lead replacement surgery due to a lead fracture had the replacement lead implanted on the right vagus nerve.This, caused the patient pain and the device had to be removed as a result.The article also contains references to other reportable events for generators which is captured in mfr report number.Additionally, the article stated that a patient had passed away due to sudep which is captured in mfr.Report 1644487-2017-03151.One unknown generator malfunction is reported in mfr.Report 1644487-2017-03153.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6309080
• MDR Text Key: 66779681
• Report Number: 1644487-2017-03152
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• 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?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/10/2017
• 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: 33 YR