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

Model Number 304-20

Device Problems Low impedance (2285); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 03/20/2019

Event Type  malfunction  

Event Description

It was reported that low lead impedance of less than 600 ohms resulted from multiple system diagnostics tests although output current was ok and was successfully delivered at 1.5ma.Additionally, the patient does have painful stimulation sometimes as well.The patient was referred for surgery.Follow up was performed with the patient's physician regarding the low impedance.It was reported that there is known trauma or manipulation of the vns area, the patient does not manipulate the lead themselves, and there is no change in stimulation perception reported by the patient.No known surgery has occurred to date.No additional or relevant information has been received to date.

Manufacturer Narrative

Corrected data, initial report: initial report inadvertently stated that there was known trauma or manipulation of the vns area instead of no known trauma or manipulation.

Event Description

It was reported that there is no known trauma or manipulation of the vns area.

Event Description

Patient underwent full revision (replacement of the lead and generator).The lead was replaced due to low impedance and the generator was replaced prophylactically.It was noted that a small tear on the lead and that it was unable to be determined if the damage occurred during removal.The explanted products have not been received by product analysis 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: 8515263
• MDR Text Key: 141969582
• Report Number: 1644487-2019-00726
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2019
• Device Model Number: 304-20
• Device Lot Number: 203452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2015
• 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): Required Intervention
• Patient Age: 23 YR