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

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem Chest Pain (1776)

Event Date 06/13/2019

Event Type  malfunction  

Event Description

A report was received that a patient's device has high impedance.Further information was received that the patient originally had high impedance and now has impedance within normal limits.X-rays were performed and the neurologist reported that there were no anomalies seen.The patient is also experiencing pain across her chest.Diagnostics were attempted in different positions to check for a positional break however the impedance was within normal limits.Ap and lateral chest x-rays were received and reviewed and per the images received, the connector pin appears to be fully inserted inside the connector block.The placement of the generator is normal.The feed thru wires seem intact at pin site.The leads were located next to and just above the generator and the lead wires at the connector pins seem intact.The lead was observed in the patient¿s neck appeared to be routed toward the patient¿s left chest.A strain relief loop and bend were both present.The strain relief bend appears to be placed per labeling, with the lead placed parallel to the electrodes, except for the placement of the tie downs.Four tie-downs are also placed however not per labeling as the tie downs are not located parallel to the electrodes.No gross fractures or sharp angles were able to be visualized in the images provided.Based on the x-rays received, the cause of the high impedance cannot be determined.Note that a microfracture cannot be ruled out based on the images provided.No additional relevant information has been received to date.

Event Description

Further impedance history was received from the physician showing the impedance changed from normal to high on two occasions.Information was also received that the patient has not experienced any trauma to the lead site that could have caused wear to the lead and patient is not a twiddler.The x-ray report was also reviewed and reported no abnormalities or anomalies with the vns: "stimulator projecting over the left chest with wire~ extending into the cervical region.This obscures some details." no additional relevant information has been received to date.

Event Description

Information was received that the patient recently had high impedance again per session reports at recent, previous office visits, however, when checked in clinic, the device again had normal impedance.It was stated that the patient had several instances of normal impedance between june and the recent high impedance reading.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

Information was received that the patient was seen in clinic and their vns interrogation went "well".It was stated the office would update the representatives if the patient required another visit.It was further reported from a representative that they confirmed that the patient was seen and the impedance was within normal limits.No additional 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: 8769401
• MDR Text Key: 150456894
• Report Number: 1644487-2019-01307
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 0105425025750139
• 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,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/20/2022
• Device Model Number: 304-20
• Device Lot Number: 204646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• 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: 41 YR