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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problems Emotional Changes (1831); Depression (2361); No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2018

Event Type  malfunction  

Event Description

It was reported that high impedance was found on the patient's vns.The patient was referred for surgery.No known surgery has occurred to date to address the high impedance.No additional or relevant information has been received to date.

Event Description

It was reported that x-rays of the patient had been taken.The manufacturer has not received these x-rays for review to date.No additional or relevant information has been received to date.

Manufacturer Narrative

Description of problem/event, corrected data: follow-up #2 inadvertently did not include the information received of increased depression and emotional changes.Patient code, corrected data: follow-up report #2 inadvertently did not include new patient coding for reported event.

Event Description

Information was received the patient was having an increase in depression and emotional changes.It was reported that the patient underwent a full replacement due to battery depletion and high impedance.An attempt was made to have the device returned to manufacturer but per the pathologist at the site, it is discarded in pathology.

Event Description

Clinical notes containing the physician's review of ct and x-ray scans were received.It was reported that front and lateral radiographs of the cervical soft tissues were taken as well as ap and lateral chest x-rays.The physician's assessment from radiographs and x-ray scans notes the presence of the vns but does not mention any anomalies with the lead or generator.Also, a picture of system diagnostics were received from the date that the high impedance was found.No relevant surgical intervention is known to have occurred 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: 7928879
• MDR Text Key: 122635308
• Report Number: 1644487-2018-01746
• Device Sequence Number: 1
• Product Code: MUZ
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/23/2009
• Device Model Number: 302-20
• Device Lot Number: 200241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/02/2018
• Supplement Dates Manufacturer Received: 10/18/2018; 11/21/2018; 04/23/2019
• Supplement Dates FDA Received: 11/12/2018; 12/14/2018; 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2006
• 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 Age: 52 YR