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

Model Number 302-20

Device Problems Mechanical Problem (1384); Device Contamination with Body Fluid (2317)

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

Event Date 08/08/2018

Event Type  malfunction  

Event Description

It was reported that during a generator replacement due to battery depletion abraded openings in the outer and inner tubing of the lead insulation was found.There was no physical trauma or manipulation of the device suspected to have caused the abraded openings.It was stated that pre-operative system diagnostic results were within normal limits indicating the device was functioning as normal.The lead was replaced.The explanted lead has been received.Product analysis is underway but has not been completed to date.No additional or relevant information has been received to date.

Event Description

Product analysis for the lead was approved.Analysis confirmed abraded openings in both the inner and outer silicone tubes which most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubing.Continuity checks of the returned lead portions were performed with no discontinuities identified.No other obvious anomalies were noted.No additional or 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
• 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: 7833674
• MDR Text Key: 118884470
• Report Number: 1644487-2018-01530
• 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: 10/03/2018

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: 03/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 09/11/2018
• Supplement Dates FDA Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2006
• 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: 50 YR