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

Model Number 1000

Device Problem False Alarm (1013)

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

Event Date 01/29/2019

Event Type  malfunction  

Event Description

During a programming history database periodic review, high impedance was found for this patient.The impedance later resolved and has been within normal limits ever since.Generator was noted to be explanted, but no device has been received to date.It is assumed that the device has been discarded.Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator.As indicated in the physician's manual, high lead impedance (>/= 5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction.Dhr review for the generator was performed.The generator passed final functional and quality specifications prior to release for distribution.No further relevant information has been received to date.

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.

Manufacturer Narrative

B6.Corrected data, initial report: auto stimulation parameters was incorrectly listed.

• 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: 17686601
• MDR Text Key: 322839916
• Report Number: 1644487-2023-01245
• 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: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

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: Lay User/Patient
• Device Expiration Date: 10/15/2020
• Device Model Number: 1000
• Device Lot Number: 5978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2018
• 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: 29 YR
• Patient Sex: Female