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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problems Seizures (2063); Depression (2361)

Event Date 02/01/2019

Event Type  malfunction  

Event Description

It was reported that a patient's device was showing high impedance.A chest x-ray showed no evidence of lead discontinuity from the device to the left lower neck at the c7 level.The patient was experiencing worsening seizures and depression for the last two months, so the patient was referred for emu monitoring and possibly surgery.No known surgery has occurred to date.No additional, relevant information was received to date.

Event Description

It was reported that the patient had their vns generator and lead explanted due to the reported high impedance.The suspect product has not been received by the manufacturer for product analysis to date.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: 8538514
• MDR Text Key: 142773424
• Report Number: 1644487-2019-00759
• 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: 10/07/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2014
• Device Model Number: 302-20
• Device Lot Number: 2643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2010
• 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: 37 YR