MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL UNKNOWN

Device Problems High impedance (1291); No Apparent Adverse Event (3189)

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

Event Date 08/05/2022

Event Type  malfunction  

Event Description

During device evaluation of returned generator, high impedance was observed.No other 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.

Event Description

This generator was received in a shipment of generators on 03/01/2023 and was confirmed on (b)(6) 2023 to be returned due to a standard generator replacement per the (b)(6) hospital.This hospital has historically and currently reports any complaints or troubleshooting issues to livanova directly.Therefore if this generator was related to a true high impedance while implanted in a patient, they would have reported to us at that time they were aware.Due to privacy laws, the united kingdom cannot send implant or explant dates of the generators unless there is an active complaint alleged.Upon return this generator it showed high impedance in data history during product analysis.This will not be captured as a high impedance device malfunction as this is an expected function of the generator to record any impedance change of >25% which occurs both before implant and after explant due to not having lead connected while implanted in patient.Due to this and the information regarding all of these generators that were returned from this facility indicated to be explanted due to normal replacement, this high impedance is not indicative of a true malfunction and therefore will not be captured.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• 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: 18793403
• MDR Text Key: 336433156
• Report Number: 1644487-2024-00214
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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