MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem No Code Available (3191)

Event Date 06/01/2018

Event Type  Injury  

Event Description

It was reported that the patient¿s generator is loose in the pocket and can be flipped over.The patient has been referred to a surgeon for revision.No known surgery has occurred to date.No additional or relevant information has been received to date.

Event Description

Operative notes were received.Notes state that new generator was secured with an 0 prolene suture, which is a non-absorbable suture.It was noted that the referral was to alleviate pain.

Manufacturer Narrative

The event was attributed to the patient's physiology and therefore device evaluation is not necessary because the reported event have been determined as not related to vns therapy.

Event Description

Information was received that the patient would not be getting surgery to adjust the vns position.It was noted that the patient had lost a lot of weight which appears to have contributed to the movement but the patient no longer desires repositioning surgery.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 7704750
• MDR Text Key: 114509908
• Report Number: 1644487-2018-01212
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/22/2019
• Device Model Number: 106
• Device Lot Number: 204061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2017
• 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: 44 YR