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

Model Number 304-20

Device Problems Low impedance (2285); Device Displays Incorrect Message (2591); Impedance Problem (2950)

Patient Problems Depression (2361); No Code Available (3191)

Event Date 11/07/2016

Event Type  Injury  

Event Description

It was reported that a patient had low impedance identified on a system diagnostic test.The patient was no longer able to feel stimulation and her depression had reportedly worsened after the low impedance message was observed.The patient underwent a full replacement on (b)(6) 2016.The generator was replaced prophylactically because it had been implanted for years.The post-op impedance values after the replacement were within normal limits.No further relevant information has been received to date.

Event Description

The patient's explanted generator and lead were both reportedly discarded after surgery.

Event Description

It was reported that the patient was told that her device had moved from the vagus nerve to the carotid artery, and surgery was performed to remove the lead from the artery.No further relevant information has been received to date.

Event Description

Per the surgeon, the lead was found to be on the vagus nerve, not on the carotid artery.No other 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: 6140871
• MDR Text Key: 61309564
• Report Number: 1644487-2016-02767
• 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
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: 304-20
• Device Lot Number: 201680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2011
• 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: 63 YR