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

Model Number 302-20

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

Patient Problem Seizures (2063)

Event Date 12/30/2019

Event Type  malfunction  

Event Description

Patient presented with increased seizures and was referred for generator replacement.At the surgery, pre-operative diagnostics showed high impedance.The patient had replacement of the lead and generator.No other relevant information has been received to date.

Event Description

Product analysis was completed on the explanted generator.The device output signal was monitored for more than 24 hours in a stimulated body temperature environment, and the device provided the expected level of output current for the entire period.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.No other relevant information has been received to date.

Event Description

Product analysis was completed on the lead.An abraded opening was observed on the inner silicone tubing 1 and quadfilar coil 1 appeared to be broken approximately 4mm and 5 mm from the end of the electrode bifurcation.Scanning electron microscopy was performed at these areas and identified the area as being pitted which prevented identification of the coil fracture type.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution.With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.Setscrew marks provided evidence that at one point a good connection was present.Continuity checks were performed and no other discontinuities were identified.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
• MDR Report Key: 9836887
• MDR Text Key: 187949167
• Report Number: 1644487-2020-00454
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750092
• UDI-Public: 05425025750092
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/21/2018
• Device Model Number: 302-20
• Device Lot Number: 202909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Event Location: Other
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR