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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); High impedance (1291); Mechanical Problem (1384); Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2018

Event Type  malfunction  

Event Description

It was reported that high impedance was seen on patient's device.It was noted that during a previous follow-up visit, the physician observed low lead impedance.No other relevant information has been received to date.There has been no known surgical intervention to date.

Event Description

X-rays were taken and provided for review.The x-rays indicated that the generator was located in the patient¿s upper left chest.The connector pin can be seen coming through the second connector block.The filter feedthru 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.There was a portion of the lead that was routed behind the generator, and the lead wires appeared intact at the connector pins.A gross discontinuity was identified in the visible portion of the lead near one of the tie downs in the patient¿s neck, and the second coil at the same location appeared to be bent at a sharp angle.The cause of the patient¿s impedance issue is likely due to the observed gross discontinuity.It was reported that the patient¿s lead and generator were explanted.The explanted products have not been received by the manufacturer to date.No further relevant information has been received to date.

Event Description

The explanted lead and generator were received for product analysis.The lead underwent product analysis and was approved on 4/24/2019.During the visual analysis, the coil was observed to be broken in two locations.Pitting and residual material was observed on the coil surface.It is unknown if the break occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces.The abraded opening found on the outer silicone tubing and connector ring inner silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and connector ring inner silicone tubes.With the exception of the observed discontinuity and abraded openings the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device.The pulse generator underwent product analysis and various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8266360
• MDR Text Key: 133844302
• Report Number: 1644487-2019-00110
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/06/2020
• Device Model Number: 304-20
• Device Lot Number: 203912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• 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: 5 YR