MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number	303-30
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported through clinic notes that the patient had low impedance detected on their generator.The patient also reported having "a click and sound and a feeling around the vns generator." multiple attempts were made to the patient's neurologist; however, no further relevant information has been received to date.No known relevant surgical intervention has occurred to date.
Event or Problem Description
It was reported that the patient received a "clicking stimulating of a short burst in her left chest regularly although not severe pain." it was reported that the patient's generator was prophylactically replaced.The explanted generator has not been received by the manufacturer for product analysis to date.It was reported that the patient's generator exhibited low impedance which was corrected by untangling the lead and replacing the generator.No further relevant information has been received to date.
Event or Problem Description
The explanted generator was received by the manufacturer for product analysis; however, product analysis has not been completed to date.No further relevant information has been received to date.
Event or Problem Description
Product analysis was completed on the returned generator.The reported allegation of noise was not duplicated in pa as there were no audible sounds identified.Additionally, the allegation of low impedance was not duplicated in product analysis with various electrical loads attached to the generator.Proper functionality of the pulse generator and its ability to provide appropriate programmed output currents was verified.The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.The device output signal was monitored for more than 24-hours while the pulse generator was placed in a simulated body temperature environment.The results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.Diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• Common Device Name: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9434088
• Report Number: 1644487-2019-02364
• Device Sequence Number: 479609
• Product Code: LYJ
• UDI-Device Identifier: 05425025750122
• UDI-Public: 05425025750122
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/05/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/21/2018
• Device Model Number: 303-30
• Device Lot Number: 308152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Event Location: Other
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 12/16/2019; 01/13/2020; 02/04/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 01/06/2020; 02/03/2020; 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR