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 09/19/2018

Event Type  malfunction  

Event Description

It was reported that during a generator replacement due to battery depletion, the surgeon noticed cracks with peeling in the lead insulation.The surgeon stated the damage was due to the fact that no strain relief had been placed in the neck.The surgeon elected to replace the lead as well.The generator has not been received into analysis to date.The lead has not been received into analysis to date.

Event Description

The generator and lead were received by the manufacturer.Analysis is underway, but has not been completed to date.No additional relevant information has been received to date.

Event Description

Analysis was performed on the returned generator.No performance or any other type of adverse conditions were found with the pulse generator.Analysis was performed on the returned lead.During the visual analysis several abraded openings were observed on the outer silicone tubing.The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.Abrasions were also found on the connector pin inner silicone tubing.With the exception of the abraded openings on the outer and connector pin inner silicone tubing, the condition of the returned lead portion is consistent with those that typically exist following an explant procedure.No other obvious anomalies were noted.Note that since the electrode array section was not returned, an evaluation and resulting commentary cannot be made on that portion of the lead no additional 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: 7957901
• MDR Text Key: 123494078
• Report Number: 1644487-2018-01808
• 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,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2008
• Device Model Number: 302-20
• Device Lot Number: 1095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2005
• 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 Age: 19 YR