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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2018

Event Type  malfunction  

Event Description

It was reported that high impedance was detected on the patient's generator.X-rays were reviewed by the manufacturer.Per the x-rays, although the angle of the image makes it impossible to visualize the pin past the second connector block, based on the ridges in the lead pin compared to the connector blocks, the lead pin is likely fully inserted.Strain relief was not per labeling.No apparent gross lead fractures were observed; however, there was a sharp angle in the lead below the electrodes.The cause of the patient¿s high impedance could not be determined based on the images provided.Note that the presence of a micro-fracture and/or a lead could not be ruled out.Data review confirmed that high impedance had been detected on the generator.No known relevant surgical intervention has occurred to date.No further relevant surgical intervention has occurred to date.

Event Description

The patient under generator and lead replacement due to high impedance.Suspect product return is not expected.No further relevant information has been received to date.

Manufacturer Narrative

Age at time of event, corrected data: the initial mdr inadvertently reported the patient age as (b)(6) instead of (b)(6).

• 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: 8932651
• MDR Text Key: 155636205
• Report Number: 1644487-2019-01658
• 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,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2013
• Device Model Number: 302-20
• Device Lot Number: 2456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2009
• 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 Age: 53 YR