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 Paresis (1998); Pneumonia (2011)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

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 livanovas 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 "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that patients left vocal cord is weak and right vocal cord compensates for the left.Patient is reported to have pneumonia.Patient has been referred for battery replacement.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

B5.Describe event; corrected information; d6b.Explant date; f10.Health effect - impact code; h6.Type of investigation; initial mdr inadvertently omitted information known prior to submission.

Event Description

It was reported that patient had a battery replacement.Explanted device has not been returned to date.No other relevant information has been received to date.

Manufacturer Narrative

B5.Describe event; corrected information; initial mdr inadvertently omitted information known prior to submission.

Event Description

It was reported that patient saw ent for vocal cord paralysis.As of 04/22 vocal cord paralysis was improving.Nurse reports that notes do not indicate anything specific related to cause of pneumonia.As of 2022, the last time patient had pneumonia was in 2016 when patient was intubated so nurse does not believe pneumonia and vocal cord paralysis are related.Patient is medically complex so this is hard to determine.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: 15474640
• MDR Text Key: 300555541
• Report Number: 1644487-2022-01180
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 00542502575040
• UDI-Public: 0542502575040
• 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: 11/02/2022

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: 11/17/2022
• Device Model Number: 1000
• Device Lot Number: 6782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 10/18/2022; 10/28/2022
• Supplement Dates FDA Received: 10/18/2022; 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2020
• 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 Outcome(s): Required Intervention; Disability; Other
• Patient Age: 15 YR
• Patient Sex: Female