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

Model Number 302-20

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

Patient Problems Dyspnea (1816); Pain (1994); No Code Available (3191)

Event Date 02/15/2019

Event Type  Injury  

Event Description

It was reported that the patient has had pain, stridor, and the feeling of nerve pulling.The patient had lost sixty pounds.The patient was referred for surgery to replace and reposition the generator.Programming history was reviewed for the patient and was only available on the date of implant.No anomalies were seen.Surgery is likely but has not occurred to date.There is no additional or relevant information received to date.

Event Description

The patient was replaced due to prophylactic replacement.The device was discarded and has not been returned to livanova to date.No additional or 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: 8412313
• MDR Text Key: 138529243
• Report Number: 1644487-2019-00469
• 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
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2013
• Device Model Number: 302-20
• Device Lot Number: 201198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2009
• 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: 33 YR