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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problems Seizures (2063); No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2019

Event Type  Injury  

Event Description

It was reported that the patient's device was showing high impedance.It was noted that in (b)(6) 2018, the patient's impedance was within normal limits.X-rays were received for review.Per the x-rays, the generator placement appeared to be normal in the left axillary chest area.The feed through wires appeared intact and the lead pin appeared to be fully inserted into the generator connector block.The lead was observed in the chest and neck.Due to the quality and scope of the images, the presence of the strain relief bend and loop per labeling could not be determined.No tie downs were present securing the lead as recommended per labeling.Part of the lead was behind the generator and could not be assessed.In the portions of the lead visible, no gross lead fractures or other anomalies were observed.No known surgery has occurred to date.No additional, relevant information was received to date.

Event Description

During attempts at product return, it was revealed that the explanted product was not kept by the facility.

Event Description

An implant form was received for a patient's full revision surgery due to high impedance.No device was received to date.No additional, relevant information was received to date.

Event Description

A response to follow-up from the physician's office reported that the patient's device was disabled because the patient was experiencing more severe and frequent seizures.It was stated that it was concluded that there was a lead issue, though the cause was not fully identified as a microfracture or lead disconnection was probable but no complete evidence was available.It was stated that the lead needed to be revised.No known surgery has occurred to date.No additional, relevant information was 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: 8424867
• MDR Text Key: 138932475
• Report Number: 1644487-2019-00510
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/18/2013
• Device Model Number: 302-20
• Device Lot Number: 201126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2009
• 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: 57 YR