MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Fracture (1260); Mechanical Problem (1384); Device Contamination with Body Fluid (2317)

Patient Problem Neck Pain (2433)

Event Date 10/09/2018

Event Type  malfunction  

Event Description

It was reported that the epileptologist ordered x-rays for this patient because there was an issue with the leads.X-ray assessments were received and stated that the device has an unchanged appearance, and the reason for the exam was that the device was not working.Device leads were noted and were stated to be unchanged compared with appearance on chest x-ray from (b)(6) 2018.Clinic notes dated (b)(6) 2018 state that the patient is not feeling the device, but it burns in the left posterior neck when the patient swipes the magnet and no reported side effects.Diagnostics from this visit were indicated to be abnormal because the lead impedance is high.The doctor decreased the pulse width, and it was stated that this was much better tolerated.The physician stated that the cause of the burning paint the patient is experiencing is unknown.Clinic notes were also received from (b)(6) 2018 stating that the vns was interrogated and is functioning normally and diagnostics were stated to be ok at this time.Later in the clinic notes the physician states that they ¿will investigate lead disfunction in vns¿ and ordered x-rays at that time.X-rays were provided and reviewed by the manufacturer.Chest x-rays were not provided and therefore the generator was unable to be assessed.The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest.No sharp angles or gross discontinuities were identified in the visible portion of the lead.The cause of the patient¿s painful stimulation could not be determined based on the images provided.Note that incomplete pin insertion and the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was reported that this patient received a generator and lead replacement due to pain in the neck and prophylactic generator replacement.The lead was returned and underwent product analysis and abraded openings were found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.Abraded openings were also observed on the outer and inner silicone tubing.Other than the above mentioned observations, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted except for the observed abraded openings.Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8088687
• MDR Text Key: 127876625
• Report Number: 1644487-2018-02106
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2016
• Device Model Number: 304-20
• Device Lot Number: 202275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 14 YR