MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cognitive Changes (2551); No Information (3190)

Event Date 03/01/2019

Event Type  malfunction  

Event Description

It was reported that the patient was referred for vns replacement due to end-of-service.Clinical notes were received which reported that the patient did not feel the vns has been working properly which was the reason to check the device.Also, the patient reports experiencing a ¿mental fog¿ due to the vns not working properly.The neurologist was unable to communicate with the patient's device at the visit.Follow up was performed with the patient's neurologist for additional information, and it was reported that the physician suspected the device's battery was depleted.However, it is unclear at this time if these events began at the time the device's battery depleted.A battery life estimation was performed with the available programming data an did not support an end-of-service status.No relevant surgical intervention is known to have occurred to date.No additional or relevant information has been received to date.

Manufacturer Narrative

Per the incoming report, the suspect product has been updated from the generator to the lead, as a device malfunction was discovered during the patient's replacement surgery.All applicable fields have been updated with the new product information.

Event Description

Implant card was received confirming that both generator and lead were explanted due to battery depletion and high lead impedance.It was reported that interrogation of patient prior to going to surgery resulted in a high impedance reading.The surgeon implant the new generator first to see if it resolved the issue.It was noted that after placing the new generator and checking the pin placement and moistening the pocket, the impedance was still out of range.The surgeon visually inspected the lead, and discovered that "at the curl of the lead" a break in one of the wires within the lead appeared.Once the lead was replaced and the generator was placed, a successful interrogation was achieved.It was noted that the hospital disposed of the battery and lead per the hospital policy.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 8541853
• MDR Text Key: 142819634
• Report Number: 1644487-2019-00764
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/06/2008
• Device Model Number: 302-20
• Device Lot Number: 1022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2005
• 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: 47 YR