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

Model Number 302-20

Device Problems Fracture (1260); Device Contamination with Body Fluid (2317); Naturally Worn (2988); Output below Specifications (3004)

Patient Problems Chest Pain (1776); Neck Pain (2433)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

It was reported that the patient was experiencing painful stimulation in the jaw, neck, and shoulder (left side).The patient initially was unable to have the vns disabled due to generator implant depth, so the patient went to the er and as given a magnet to disable stimulation.The vns was able to be interrogated and disabled the next day.The patient has reported that the pain has improved, but she still feels discomfort around the generator pocket.The patient denies any trauma to the vns location.The patient was noted to have gained weight since implant, which is what likely contributed to the failure to program.It was also noted that low output current was seen.Based on an ohm's law calculation, the low output current could not be attributed to high programmed settings.No known relevant surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

Additional information was received indicating that high impedance was seen on the patient's vns.Upon interrogation the vns was off, and when the orss programmed the vns back on, the patient reported coughing and painful stimulation.Therefore, the low output current can be attributed to high impedance.No known relevant surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

The patient underwent full revision, and it was noted that there was damage to the lead insulation.After full revision the impedance was within normal limits.The explanted generator and lead were received by the manufacturer.Product analysis has not been completed for the suspect device to date.No additional relevant information has been received to date.

Event Description

Generator product analysis (pa) was completed.The alleged ¿low output current¿ was not verified in the pa lab.The output current was measured for >24 hours and there was no variation in the expected delivered output, and it was demonstrated that the generator delivered the expected output current for the entire monitoring period.Comprehensive electrical testing showed that the generator performed according to all functional specifications.There were no performance, or any other type of adverse conditions found with the pulse generator.Product analysis has not been completed on the suspect device to date.

Event Description

Product analysis (pa) was completed on the suspect lead.Abraded openings were noted in both the outer and inner tubing with associated fluid leaks within the inner and outer tubing.The presence of a lead fractures was confirmed.No other anomalies were noted.No additional 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: 12236038
• MDR Text Key: 263850827
• Report Number: 1644487-2021-01026
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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: 03/01/2022

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: 04/01/2010
• Device Model Number: 302-20
• Device Lot Number: 200485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 08/04/2021; 10/18/2021; 11/17/2021; 02/04/2022
• Supplement Dates FDA Received: 08/27/2021; 11/12/2021; 12/02/2021; 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2007
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female