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

Model Number 304-20

Device Problem High impedance (1291)

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

Event Date 03/20/2019

Event Type  malfunction  

Event Description

The physician reported a high impedance warning message on patient's vns system.The interrogation showed that the generator's output current was not being delivered, and that the impedance was high.The physician performed x-rays and found no issues.Ap and lateral neck and chest x-rays were received and reviewed regarding the reported high impedance.Based on the images provided, the feedthrough wires integrity could not be assessed at the connector pins, due to the angle of the generator and quality of the image.However, the lead pin appeared to be fully inserted through the connector block.The device was placed in the patient¿s left chest per labeling, and the lead was observed in the neck and chest.Portions of the lead were not visible due to poor image quality and therefore could not be assessed.Due to the image quality, the integrity of the lead wires at the connector pin was unable to be assessed.In the portions of the lead visible, no gross lead fractures or other anomalies were observed.There was a portion of the lead that appeared to be placed behind the generator with no visualization of damage; however, the visibility of the x-ray was poor in this region.The patient underwent lead revision surgery, and it was noted that during surgery lead pin re-insertion was attempted; however, the high impedance still remained after pin re-insertion.It was decided that the lead would be explanted and replaced.It was reported that the high impedance resolved once the lead was replaced.The surgeon visually inspected the explanted lead and did not see any issues with the lead.The explanted product has not been received to date.No other relevant information has been received to date.

Event Description

The explanted lead was received by the manufacturer and underwent product analysis.The condition of the returned lead portion was consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The 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 portion confirmed no discontinuities.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion.Note that since the majority of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.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: 8510231
• MDR Text Key: 141793087
• Report Number: 1644487-2019-00712
• 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
• Report Date: 05/31/2019

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 Expiration Date: 11/01/2021
• Device Model Number: 304-20
• Device Lot Number: 5502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 05/07/2019
• Supplement Dates FDA Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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: 22 YR