MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Fracture (1260); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Seizures (2063); Neck Pain (2433)

Event Date 11/21/2018

Event Type  malfunction  

Event Description

The patient's neurologist reported that they interrogated the device because the patient was having some discomfort.Upon interrogation, high impedance was observed and the neurologist thought there could be a disconnection along the electrode and stated that ¿the device cannot transmit the proper stimulation to the patient¿s vagal nerve." additional information was received that the patient has been referred for a revision.It was stated that the patient's discomfort is occurring in the neck area and is associated with stimulation.There was no trauma reported to that area, and the physician does not have an assessment of the cause of the patient's discomfort.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

Event description, corrected data: initial report inadvertently did not indicate information from the received clinic notes.Patient code, corrected data: initial report inadvertently did not list an additional patient code.

Event Description

Clinic notes were received which indicated that the patient has been having slightly more seizures although it was stated to be subtle; the patient¿s mother suspects it is present.The vns device was interrogated and it was stated that high lead impedance was observed, which the doctor suspected would indicate a break in the line.It was also stated that there is evidence of sub-optimal control of the patient¿s seizures ever since she has felt discomfort in her neck.The neurologist believes there is an impedance break in her circuit from the stimulator cabling as a strong possibility to explain the behaviors of shock-like sensation.No other relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

It was reported that this patient received a full generator and lead replacement due to high impedance, and the explanted products were discarded after surgery.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 8146223
• MDR Text Key: 129776047
• Report Number: 1644487-2018-02253
• 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,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/10/2008
• Device Model Number: 302-20
• Device Lot Number: 1169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 12/18/2018; 03/06/2019
• Supplement Dates FDA Received: 12/18/2018; 03/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2005
• 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: 34 YR