MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Chest Pain (1776); No Code Available (3191)

Event Date 01/20/2021

Event Type  Injury  

Event Description

It was reported that the patient has been referred for surgery as the generator has migrated to her armpit.It was noted that the patient was active in post-op period.Per the physician, the generator migration is due to patient manipulation.It was noted that the patient played softball when advised otherwise on both discharge instructions post operatively and at 2 weeks follow up on (b)(6) 2020.Per the physician, the scheduled surgery is due to discomfort of the battery.No additional relevant information has been received to date.

Event Description

It was reported patient attended clinic visit due to pain caused by possible migration.Surgeon reports that there was no migration identified during time of surgery.Surgeon identified that the surrounding area of the pocket in the subcutaneous space was calcified.Surgeon moved generator more medially and sutured the generator in place.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 11286289
• MDR Text Key: 230492554
• Report Number: 1644487-2021-00184
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

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: 02/18/2022
• Device Model Number: 1000
• Device Lot Number: 205213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 07/15/2022
• Date Device Manufactured: 11/19/2020
• 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: 16 YR
• Patient Sex: Female