MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number 303-20

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/29/2023

Event Type  malfunction  

Event Description

It was reported that upon interrogation high impedance, low output current was seen.Additionally the patient's psychiatrist and surgeon state that they are now planning for a lead revision.X-rays were taken and the physician was able to see a lead fracture.They also noted that the leads had twisted and likely contributed to the fracture.The reason for the twisting is unknown per the physician.They did note that the patient fell and there is a history of weight loss in the last year which may have created subcutaneous ¿space¿ for twisting and possible ¿knotting¿.Ap chest x-ray was received and reviewed.The generator placement could not be assessed based on the scope of the image.Based on the available portion of the lead in the image, a gross fracture can be seen in the middle portion of the lead above the generator.This could be due to the twisting and coiling seen in the provided image.The lead pin and feedthru wires could not be assessed due to the scope of the image.Based on the x-rays received, the cause of the high impedance is due to the lead fracture seen.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

F10 health effect, clinical code: code e2402 utilized; appropriate term ¿migration¿ is not available.(note that although migration is an available medical device problem code, in this report¿s context, the migration does not reflect a problem with the functionality or delivery of therapy of the device.Therefore, a device problem code does not adequately capture the patient¿s adverse event.) 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

Per the physician, the lead break was confirmed on the x-ray shortly after the high impedance was first seen.The surgeon indicated that non-resorbable sutures were used and noted that it is possible the weight loss contributed to the twisting of the leads as a larger subcutaneous pocket would have formed.There was no trauma or manipulation.Since the reported event a lead revision has been completed.The explanted lead was discarded after it was removed.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• 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: 17377616
• MDR Text Key: 319943430
• Report Number: 1644487-2023-00975
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 303-20
• Device Lot Number: 6816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• 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: 43 YR
• Patient Sex: Female