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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); Device Contamination with Body Fluid (2317)

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

Event Date 08/07/2018

Event Type  malfunction  

Event Description

It was reported that high impedance was found on the patient's device.The patient's generator was disabled due to the high impedance and the patient was referred for surgery.No relevant surgical intervention is known to have occurred to date.No additional or relevant information has been received to date.

Event Description

The explanted lead and generator were returned to the manufacturer.An analysis was performed on the returned lead portions.During the visual analysis of the lead a break in the lead coil with pitting and residual material were observed on the coil surface.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.During the visual analysis a second coil break was identified with no pitting.Abraded openings were found on the outer and inner silicone tubing which most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubing.With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator.Additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device.Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.An analysis was performed on the returned pulse generator.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.Additionally, the internal memory of the generator revealed that lead impedance changed from 5,447 ohms (high) to 7816 ohms (high) on 8/7/2018.There were no performance or any other type of adverse conditions found with the pulse generator.No additional or relevant information has been received to date.

Event Description

The patient underwent a generator and lead replacement.The explanted devices have not been received to date.No additional or 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: 7912479
• MDR Text Key: 124011248
• Report Number: 1644487-2018-01704
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/16/2018
• Device Model Number: 304-20
• Device Lot Number: 203179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2014
• 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: 14 YR