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

Model Number 302-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 06/01/2016

Event Type  Injury  

Event Description

It was reported that the patient started experiencing a pulling sensation on her lead that was causing pain.The patient saw a surgeon, and the physician agreed to explant the device.Surgical intervention has not occurred to date.No additional pertinent information has been received to date.

Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy or functionality of the device.

Event Description

The patient's generator and lead were explanted which was noted to be due to low battery and patient request.The devices were returned for analysis however device evaluation is not necessary because the reported events are not related to the functionality or delivery of therapy of the device.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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 6693872
• MDR Text Key: 79291382
• Report Number: 1644487-2017-04107
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2005
• 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: 52 YR