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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260)

Patient Problem Emotional Changes (1831)

Event Date 12/15/2017

Event Type  malfunction  

Event Description

It was reported that the patient was referred for replacement.It was indicated that the reason for the referral was due to high impedance, and that the patient has experienced mood swings, which may be caused by the high impedance.No known surgical intervention has occurred to date.No additional or relevant information has been received to date.

Event Description

The patient underwent a full replacement surgery.The explanted devices have not been received for analysis to date.

Event Description

The generator and lead were both returned to the manufacturer for analysis.Analysis has been performed on 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.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.Analysis has not been completed on the lead to date.

Event Description

Product analysis for the lead was completed and approved.An analysis was performed on the returned lead portions of the lead.A portion of the lead assembly was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis of the returned portion, the coil appeared to be broken approximately 2mm from the end of the electrode bifurcation area.Scanning electron microscopy was performed on the connector end of the coil break (found at 2mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting and residual material on three of the broken coil strands.Low magnification sem analysis of the 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.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7654801
• MDR Text Key: 112873977
• Report Number: 1644487-2018-01111
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/11/2018

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: 04/10/2008
• Device Model Number: 302-20
• Device Lot Number: 1028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 08/02/2018; 09/05/2018; 10/03/2018
• Supplement Dates FDA Received: 08/27/2018; 09/28/2018; 10/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2005
• 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: 55 YR