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

Model Number 304-20

Device Problem Fracture (1260)

Patient Problem Cramp(s) /Muscle Spasm(s) (4521)

Event Date 05/05/2023

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 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 patient appeared in clinic with high impedance.The battery life is noted to be low.The patient is having a decreased perception of stimulation and is also experiencing muscle spasms of the chest.The plan is to refer the patient for surgery (patient has not been officially referred for replacement to date).It was later reported by the physician that the cause of the muscle spasms is due to vns stim (likely related to the high impedance).The patient is also now referred for surgery.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was reported that the patient's generator was replaced and high impedance was still seen.The patient is referred for lead replacement.No other relevant information has been received to date.

Event Description

It was reported that the patient (b)(6) lead was replaced.The explanted lead was noted to be discarded by the explanting facility.

Manufacturer Narrative

H6.Describe event; adverse event problem codes; initial mdr inadvertently omitted information known prior to submission.F7.Type of report; follow up # was not selected in prior mdr, this mdr skips over prior follow up# to remain consistent.This is being noted to call out the missed follow up # in prior mdr.

• 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: 17019350
• MDR Text Key: 316115526
• Report Number: 1644487-2023-00686
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/11/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/18/2019
• Device Model Number: 304-20
• Device Lot Number: 4356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/30/2023
• Supplement Dates Manufacturer Received: 06/01/2023; 06/22/2023; 08/11/2023
• Supplement Dates FDA Received: 06/21/2023; 07/17/2023; 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2015
• 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): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female