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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Seizures (2063); Fibrosis (3167)

Event Date 09/24/2018

Event Type  malfunction  

Event Description

It was reported that the patient was hospitalized due to increased seizures, and increased seizure duration and intensity.A company representative then checked the patient's generator and found high impedance and that the current was not being delivered.A new lead and generator were implanted on the right side of the patient.The generator was explanted, but the old lead was left in the patient in its entirety.Per the surgeon, no fluid or visible defects were seen on the lead.The physician believes the high impedance to have been due to scar tissue on the left vagal nerve.Attempts have been made for lead product information, but no relevant information has been received to date.No additional relevant information has been received to date.

Event Description

Additional information was received from a company representative.It was a system diagnostics that was run in the emergency room that resulted in high impedance.The representative also found the output current disabled at the time.Attempts for information have been made to the physician, but no additional 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7975863
• MDR Text Key: 124132662
• Report Number: 1644487-2018-01839
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2009
• Device Model Number: 302-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 25 YR