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

Model Number 304-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Nerve Damage (1979); Vomiting (2144); Weight Changes (2607)

Event Date 03/27/2019

Event Type  Injury  

Event Description

It was reported that the patient has had a fever, severe vomiting, and weight loss following vns replacement surgery.The patient was hospitalized, and the patient reported that the physicians believe that the patient has acute gastritis caused by damage to the vagus nerve.The device was not turned on following replacement.The patient was later released for the hospital.During the full replacement surgery, it was reported by a sales representative that there wasn¿t anything abnormal.The lead impedance was normal and the device was not programmed on.Device history records were reviewed for the generator and lead.There were no unresolved non-conformities, and the devices passed all specifications prior to distribution.No additional or relevant information has been received to date.

Manufacturer Narrative

(b)(4).

• 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: 8637187
• MDR Text Key: 145966242
• Report Number: 1644487-2019-01013
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/06/2022
• Device Model Number: 304-20
• Device Lot Number: 204698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2018
• 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 Outcome(s): Hospitalization
• Patient Age: 73 YR