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 Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 05/10/2023

Event Type  Injury  

Event Description

It was reported that patient's device was explanted due to infection.Device history records were reviewed.The device was found to be hp sterilized prior to distribution.Device evaluation is not necessary as it will add no value to the investigation.The physician has reported that the date of explant was two months post op.Indicates due to operative wound infection and dehiscence.Historical data analysis concludes the cause of the infection is known to be related to surgery and an inherent risk.The cause of the wound dehiscence is unknown.No other relevant information has been received to date.

Manufacturer Narrative

H3.Device evaluated by mfr; code 81, device evaluation and return of the device is not necessary.It will not add value to the investigation.Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova 39; s employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any 34; defects¿ or 34; malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

Information was later received indicating the date infection was first seen.The patient was noted to have also been placed on antibiotics at the time.No other relevant information has been received to date.

Event Description

Clinic notes were received stating patient was explanted due to infection in early july, contradicting the previously reported exported date.The physician later provided the true explant date.No other relevant information has been received to date.

Manufacturer Narrative

D6b.If explanted, give date (mo/day/yr); corrected data; new information received contradicts reported explant date on initial mdr.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17652491
• MDR Text Key: 322310129
• Report Number: 1644487-2023-01226
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2024

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 Model Number: 106
• Device Lot Number: 7383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 10/05/2023; 02/22/2024
• Supplement Dates FDA Received: 10/30/2023; 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2022
• 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: 25 YR
• Patient Sex: Male