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 Pocket Erosion (2013); Dizziness (2194); Post Operative Wound Infection (2446); Syncope/Fainting (4411)

Event Date 04/06/2022

Event Type  Injury  

Event Description

It was reported that the patient was just recently implanted with no problems and then a few days later started experiencing chest discomfort.The patient then started feeling dizzy one day and fainted and reported that her chest was hurting badly.The patient went to the hospital and x-rays were done and the patient was given medication for the pain and then two weeks later the patient felt the generator rotate within the pocket and it is now protruding.Additional information was obtained noting that the patient was seen in the surgeon's office and an infection was confirmed so the patient was prescribed antibiotics.It was also confirmed that the movement reported was normal.A device history records (dhr) review was performed and the generator was confirmed to have been hp sterilized prior to distribution into the field.The device passed all specifications, including quality control inspection, and showed no non-conformities, prior to its release into the field for distribution.No other relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

B5 describe event or problem, corrected data: initial report inadvertently left out relevant information d6b.If explanted, give date (mo/day/yr), corrected data: initial report inadvertently did not note the explant date f10.Adverse event problem , corrected data: initial report inadvertently left out codes 'e1713' and 'f1903' h6.Adverse event problem codes, corrected data: initial report inadvertently left out code 'd1101'.

Event Description

Additional information received noting that the patient is having their device explanted due to an infection and their device being exposed caused by the patient picking at their skin.

Event Description

Additional information received indicating that the mrsa infection has resolved.

• 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: 14473993
• MDR Text Key: 292507910
• Report Number: 1644487-2022-00595
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2023
• Device Model Number: 1000
• Device Lot Number: 7030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2021
• 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; Hospitalization
• Patient Age: 18 YR
• Patient Sex: Female