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

Model Number 302-20

Device Problems Fracture (1260); High impedance (1291); Insufficient Information (3190)

Patient Problem Depression (2361)

Event Date 09/01/2016

Event Type  malfunction  

Event Description

It was reported through clinic notes that the patient's generator was at end of life and had high impedance that suggested that the generator was nonfunctional.The physician indicated that the patient had a lower mood for the prior two months and that these recent depressive symptoms could be secondary to device failure/low battery.Five months prior the vns was checked and was reportedly working correctly with no adverse events or other problems.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

Follow up with the physician found that the patient's system diagnostics had indicated high impedance and that the patient's depression was worse than pre-vns levels.No known relevant surgical intervention has occurred to date.No further relevant information has been received, to date.

Event Description

It was reported that this patient's generator was replaced due to battery depletion.High impedance was detected on the patient's new replacement generator.No further relevant information has been received to date.

Event Description

It was reported by the physician that at the last appointment two weeks prior the patient's impedance had been okay and the patient was set to 0.75 ma output current; however, that day, the patient's impedance was high and the output current delivered was 0 ma.Product analysis was completed on the returned generator and end of service condition was verified the device performed according to the specifications of the post-burn electrical testing with no anomalies found.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported that the patient's lead was replaced due to high impedance.The explanted product has not been received to date.No further relevant information has been received to date.

Event Description

It was reported from clinic notes that there was a gap where vns was not working.No other relevant information has been received to date.

Event Description

Further information was received that the report of device not working was in reference to the device being at eos which caused the worsened mood.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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 6433793
• MDR Text Key: 70865332
• Report Number: 1644487-2017-03458
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/06/2023

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: 02/28/2010
• Device Model Number: 302-20
• Device Lot Number: 200419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided; 08/31/2017; 09/28/2017; 11/07/2017; 12/22/2022; 01/12/2023
• Supplement Dates FDA Received: 05/03/2017; 09/26/2017; 10/23/2017; 12/04/2017; 01/10/2023; 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2007
• 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
• Treatment: NA.
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female