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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384); Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2017

Event Type  malfunction  

Event Description

At a generator replacement planned due to low battery, it was reported that high impedance was detected preoperatively, replacement of the generator did not resolve the high impedance, so the lead was replaced.The surgeon noted fluid in the leads, and when the patient's neck incision site was opened, it was found that there was a break in the lead at the electrodes.The suspect product was received but analysis has not been completed on the device to date.No further relevant information has been received to date.

Event Description

Product analysis was completed on the returned generator.As received, the generator was at end of service condition.Per functional and electrical tests, the generator performed as expected with no anomalies identified.Product analysis was completed on the returned lead.Product analysis identified six abraded openings in the outer tubing along the lead body.There was one abraded opening in both the outer and inner tubing.Body fluids were located in the inner and outer tubing in some places.Four lead fractures were identified.At the fracture closest to the connector pin, microscopic an abraded opening was identified.The inner and outer abraded opening was located near the middle fractures, which were located right next to each other.Pitting was identified at the two middle fractures.Of the fracture types that could be identified, there was evidence of stress induced fractures, both rotational and fatigue types.Due to the presence of pitting at some of the fracture sites, it is believed that stimulation was present for some amount of time after the fracture with the exception of the observed abraded openings (outer and inner tubes) and discontinuities the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.No further relevant information has been received to date.

• 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: 8080710
• MDR Text Key: 127549035
• Report Number: 1644487-2018-02075
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/17/2015
• Device Model Number: 304-20
• Device Lot Number: 2930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2011
• 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 Age: 20 YR