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 02/18/2018

Event Type  malfunction  

Event Description

It was reported that the physician that the patient had high impedance, and that the physician believed that the generator was prematurely depleting.The physician had originally attributed the high impedance to the patient's falls.The battery had been implanted for two years and was showing intensified follow up indicator.Data was reviewed for the generator, and the generator had high impedance for over a year.The patient¿s generator had been left on at high settings.A battery life calculation was made using the patient's settings and impedance confirmed the battery depletion was expected.Surgery is likely but has not occurred to date.No additional information has been received.

Event Description

The patient was replaced.The explanting facility does not return explanted devices, therefore the lead was not returned.No additional information has been received.

• 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: 8345713
• MDR Text Key: 136615022
• Report Number: 1644487-2019-00297
• 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
• Report Date: 03/01/2019

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: 04/05/2009
• Device Model Number: 302-20
• Device Lot Number: 1609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 12 YR
• Event Location: Other
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2006
• 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: 46 YR