MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

Device Problem Fracture (1260)

Patient Problems Headache (1880); Neck Pain (2433); Unspecified Respiratory Problem (4464)

Event Date 12/23/2022

Event Type  malfunction  

Event Description

It was reported, that upon checking the device.An alert for high lead impendence was seen.The patient has been experiencing neck pain, voice changes and headaches with stimulation.And the settings were lowered, but the issue persisted.The patient was referred for revision surgery.And the full revision was confirmed, to have occurred on (b)(6) 2023.The explanted devices have not been received to date.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 & #39 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 & #34 "defects" or & #34 "malfunctions".These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.Health effect - clinical code: e210401.

Manufacturer Narrative

H3.Device evaluated by mfr? code 02; device is undergoing product analysis testing.

Event Description

The explanted device were received into product analysis and are undergoing testing.No other relevant information has been received to date.

Event Description

Functional analysis continuity checks on the returned portion of the lead were good.No discontinuities were identified during the continuity check.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17039868
• MDR Text Key: 316399140
• Report Number: 1644487-2023-00695
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 304-20
• Device Lot Number: 205317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2020
• 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): Other
• Patient Age: 46 YR
• Patient Sex: Female