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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384)

Patient Problem Neck Pain (2433)

Event Date 08/16/2017

Event Type  malfunction  

Event Description

Clinic notes were received indicating the vagus nerve stimulator is hurting the patient with a "shocking" sensation up into her neck.When it is checked, it shows normal impedance but low battery life.The patient was referred for surgery.Replacement surgery occurred on (b)(6) 2018, and during the surgery a lead fracture was found in two places and the lead was replaced as well.The explanted devices were received 06/19/2018.Analysis is underway, but has not been completed to-date.Additional relevant information has not been received to-date.

Event Description

Analysis was completed for the returned generator.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified.In addition, 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.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.The pulse generator diagnostics were as expected for the programmed parameters.Electrical evaluation showed that the pulse generator performed according to specifications.The battery measured 2.871 volts and was not in a depleted condition.The downloaded data revealed that 76.814% of the battery had been consumed.Analysis was completed on the returned lead portion.A portion of the lead assembly including the electrodes was not returned for analysis, therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis the connector ring coil was broken approximately 280mm from the end of the connector boot.Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type.Pitting and residual material were observed on the coil surface.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process.What appeared to be white deposits were observed in various locations.With the exception of the observed discontinuity the condition of the returned lead portion.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7712324
• MDR Text Key: 114804285
• Report Number: 1644487-2018-01245
• Device Sequence Number: 1
• Product Code: LYJ
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2014
• Device Model Number: 304-20
• Device Lot Number: 2723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2010
• 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: 13 YR