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

Model Number 304-20

Device Problems Air Leak (1008); Overheating of Device (1437); Low impedance (2285)

Patient Problems Seizures (2063); No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient had low impedance results on his first follow-up visit following initial implant.Two system diagnostics were performed and showed low impedance.There was reportedly no trauma that had occurred since implant, but the patient reportedly felt a "heat sensation all day" at one point.The patient reported that they had still experienced coughing when the settings were increased.It was noted that impedance values were intermittently within normal limits pre-operatively.When the patient's position changed, he sometimes got impedance values in normal limits and other times got low impedance.The physician reported that he saw a "bubble" in the connector cavity that he believed was causing the low impedance.The surgeon opted to perform generator replacement and leave the lead intact.The explanted generator has not been received to date.No further relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: the initial report inadvertently did not include information regarding post generator replacement.Relevant tests/laboratory data, including dates: the initial report inadvertently did not include the post generator replacement impedance value.

Event Description

After the patient's generator replacement surgery on (b)(6) 2016, the impedance values were within normal limits.It was reported that the explanted generator would not be returned for analysis per the explant facility's policy.X-rays were provided to the manufacturer for review.The a/p chest x-ray showed that the lead pin was fully inserted into the connector block, the feedthru wires appeared intact at the connector block, and the generator was placed normally in the left chest just below the clavicle.A portion of the lead was found routed behind the generator.No gross lead discontinuities were identified, no sharp angles were identified, and the lead appeared intact at the connector pin.An assessment could not be made on the portion of the lead routed behind the generator.Therefore, the presence of a microfracture and any additional information regarding the lead portion behind the generator cannot be assessed.No additional relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: supplemental report #1 inadvertently did not include notice that the generator had been returned.

Event Description

The explanted generator was returned for analysis.Historical diagnostic data was also provided and reviewed.Historical found the date that the low impedance message was first identified and verified that the impedance had bounced back up as previously reported to about 2,000 ohms at one time.The explanted generator is currently undergoing analysis.

Event Description

The explanted generator was returned and had product analysis completed, verifying that the generator was able to accurately measure impedance values.This verified that there was an intermittent short circuit in the lead.Negative impedance values were measured when there was a 0 ohm load applied to the generator.

Event Description

Full analysis was completed on the generator and confirmed its ability to accurately measure impedance values.The device was placed in a simulated body environment and the generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The generator was subjected to multiple electrical loads and verified the ability to accurately measure impedance values within an appropriate range.The generator septum was visually analyzed and verified that it was not cored.No other surface anomalies were identified on the generator.The generator performed according to all functional specifications with respect to accurately measuring impedance values.

Event Description

It was reported that the original lead is still implanted and is working fine with the replacement vns device.

Event Description

It was reported that the patient felt extreme heat and could not move for 24 hours.It was also reported that the patient experienced an increase in seizures due to the low impedance and the device not supplying stimulation.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5950353
• MDR Text Key: 55113000
• Report Number: 1644487-2016-02078
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/07/2019
• Device Model Number: 304-20
• Device Lot Number: 4553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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: 16 YR