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 Hematoma (1884); Hemoptysis (1887); Post Operative Wound Infection (2446)

Event Date 09/08/2023

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

Event Description

The patient reported that she had coughed up frank red blood.No other relevant information has been received to date.

Manufacturer Narrative

This report was due on november 25, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 20, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.

Event Description

Additional information received noting that the patient was admitted to the hospital for an emergency surgery due to an abscess at the throat surgery site.The patient was being treated with iv antibiotics and had an on and off fever with some white blood cell elevation.During the surgery, nothing abnormal was seen besides a hematoma that was cultured.The device was checked and the impedance was within normal limits.The cultures came back positive for staph aureus and the patient was sent home on keflex, which the staph had a sensitivity to.This resulted in the patient's neck incision is now more swollen and having some clear and blood drainage.

Manufacturer Narrative

H6 adverse event problem, corrected data: supplemental #01 report inadvertently did not code 'b01' for type of investigation and 'c19' for investigation findings.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17945085
• MDR Text Key: 325797045
• Report Number: 1644487-2023-01482
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2024

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: 1000
• Device Lot Number: 7631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 10/26/2023; Not provided
• Supplement Dates FDA Received: 12/05/2023; 05/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• 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): Hospitalization; Other
• Patient Age: 40 YR
• Patient Sex: Female