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

Model Number 304-20

Device Problems High impedance (1291); Device Contamination with Body Fluid (2317); Naturally Worn (2988); Incomplete or Inadequate Connection (4037)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported that the doctor saw high impedance and low output current when interrogating the patient's device.There has been no recent trauma to the area.X-rays were completed and reviewed by the physician and no apparent fracture was observed.The x-rays have been mailed for review but have not been received to date.Per the physician, the believed cause of the high impedance is incomplete pin insertion, however this has not been confirmed.A revision surgery has been planned.Device history records were reviewed.The device passed all functional specifications and quality tests and were sterilized prior to distribution.No known relevant surgical intervention has occurred 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'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

Additional information was received reporting that the lead was replaced.The device has not been received to date.No other relevant information has been received to date.

Event Description

Per the response received from the physician, there was bloody fluid inside the sheath.Ap chest and neck x-ray images were also received and reviewed.The generator was located within the patient¿s upper left chest.The connector pin was not visualized through the second connector block and appears not fully inserted.The feedthru wires were confirmed to be intact.The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest.It appears that a strain relief loop and strain relief bend were present and placed per labeling.Two tie downs can be seen and appear to be place per labeling.It is unclear if a portion of the lead is routed behind the generator as it is unclear due to image quality.The lead wires are intact at the connector pins.No sharp angles or gross discontinuities were identified in the visible portion of the lead.The cause of the patient¿s high impedance is likely related to the fluid leaks and the incomplete pin insertion observed in the images provided.Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18767067
• MDR Text Key: 336107582
• Report Number: 1644487-2024-00183
• 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
• Report Date: 04/25/2024

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
• Device Model Number: 304-20
• Device Lot Number: 206068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 03/07/2024; 04/02/2024
• Supplement Dates FDA Received: 04/01/2024; 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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: 7 YR
• Patient Sex: Male