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

Model Number 1000

Device Problems High impedance (1291); Incomplete or Inadequate Connection (4037)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  malfunction  

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

It was reported that the patient had high impedance and x-rays were taken.X-rays have not been provided to the manufacturer yet to review.The patient has not experienced any trauma or manipulation to the area, and no medical intervention has been taken for the high impedance.It was also reported that the patient tripped over some brush and fell in the woods while hunting.This occurred a couple of weeks after the generator was replaced.Patient has been referred to neurosurgeon to explore the lead.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

The patient later had a surgery where the surgeon removed the lead pin and re-inserted it into the generator.The impedance out of the pocket, in the pocket, and in different placements were measured and gave consistent readings around 2,500 ohms.

Event Description

It was later reported that the patient fell several weeks ago and landed on his chest over the generator and noticed within a day that the device was not working.A few days later, patient was seen by neurologist and high impedance was identified.

Manufacturer Narrative

B5.Corrected event description, supplemental #1 report: inadvertently left out information related to this event.

• 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: 18418926
• MDR Text Key: 331605549
• Report Number: 1644487-2023-01868
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1000
• Device Lot Number: 204569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 01/10/2024; 03/01/2024
• Supplement Dates FDA Received: 02/02/2024; 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• 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 Age: 22 YR
• Patient Sex: Male