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 05/02/2019

Event Type  malfunction  

Event Description

It was reported that the patient was interrogated and found to have a high impedance reading.An ap neck and chest x-ray image was received and reviewed by the manufacturer.Based on the images provided, the feedthru wires appeared intact at the connector pins.Due to the angle of the generator, full lead pin insertion could not be confirmed, as the lead pin could not be clearly seen coming through the second connector block.The device was placed in the patient¿s left chest per labeling.The lead was observed in the neck and chest.Note that portions of lead, especially around the generator, were not visible due to poor image quality and therefore could not be assessed.Additionally, a portion of the lead was routed behind the generator.A strain relief bend was present per labeling; however, no strain relief loop was present.Due to the image quality, the integrity of the lead wires at the connector pin was unable to be assessed.In the portions of the lead visible, no gross lead fractures or other anomalies were observed.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Patient underwent a full revision (generator and lead).The explanted lead has not been received by product analysis to date.No further 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: 8635763
• MDR Text Key: 145923037
• Report Number: 1644487-2019-01004
• 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
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2017
• Device Model Number: 302-20
• Device Lot Number: 202358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2013
• 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: 12 YR