MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 300

Model Number 300-20

Device Problems Corroded (1131); Fracture (1260); Device Contamination with Body Fluid (2317)

Patient Problem Seizures (2063)

Event Date 10/09/2018

Event Type  malfunction  

Event Description

It was reported that high impedance and low output current was detected on the patient's vns.The patient had been having an increase in seizures due to this device issue.No known surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

Product analysis was completed on the returned generator.As received, the generator performed as expected with no anomalies identified.The internal database for the generator indicated that the high impedance was detected on the generator while the generator was still implanted and connected to the leads.Product analysis was completed on the returned lead.Product analysis indicated an abraded opening in the outer and inner tubing that exposed the lead coil.The lead assembly had dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing opening and the cut end of the returned lead portion.Pitting was identified by scanning electron microscopy on the connector pin and was not found to impact device functionality.The lead's electrodes and the majority of the lead body were not returned for evaluation and therefore assessments could not be made on the portions that were not returned.With the exception of the observed abraded opening of the outer and inner tube and the observed pitting, no other anomalies were identified in the returned lead portions.No further relevant information has been received to date.

Manufacturer Narrative

Device available for evaluation?, corrected data: yes, 12/12/2018.Supplemental mdr #1 inadvertently did not include product received date.Device evaluated by mfr?, corrected data: supplemental mdr #1 inadvertently did not indicate that the device is in evaluation.

Event Description

The suspect product was received by the manufacturer.Product analysis on the explanted lead has not been completed to date.No further relevant information has been received to date.

Event Description

Incoming communication indicated that the patient underwent a full revision due to the high impedance.The full revision was unable to be completed due to surgical complications of scar tissue and bleeding from the surgical procedure (captured in emdr mfg #1644487-2018-02302).The lead and generator were explanted.The suspect product has not been received to date.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 300
• 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: 8030900
• MDR Text Key: 125907985
• Report Number: 1644487-2018-01964
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/23/2003
• Device Model Number: 300-20
• Device Lot Number: 2747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2001
• 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: 22 YR