MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problem Pain (1994)

Event Date 05/04/2018

Event Type  Injury  

Event Description

It was reported that a patient is at ifi-yes and wants the device explanted because it irritates her.She was seen in clinic and ifi-yes was seen for referral for explant was sent to discuss explant.The patient does not want it re-implanted as it irritates her and wants it out.The neurologist has been tapering the vns settings down at each office visit.No additional or relevant information has been received to date.Surgical intervention has not occurred to date.

Manufacturer Narrative

Device evaluated by manufacturer, device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy).

Event Description

Follow-up information revealed that the patient was bothered that she couldn't get an mri because of her vns so wanted it out, as she doesn't think it was effective.No additional or relevant information has been received to date.

Event Description

The had a full explant of the lead and generator.The devices are not being returned for analysis.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7560776
• MDR Text Key: 109791210
• Report Number: 1644487-2018-00904
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2015
• Device Model Number: 104
• Device Lot Number: 202547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 06/01/2018; 06/29/2018
• Supplement Dates FDA Received: 06/26/2018; 07/23/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 40 YR