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

Model Number 304-20

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

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

Event Date 02/18/2018

Event Type  malfunction  

Event Description

High impedance on the patient's device was detected through a periodic review of the manufacturer's programming history database.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

It was reported that the patient underwent a full revision of generator and lead due to high impedance.The suspect product was discarded.No further relevant information has been received to date.

Event Description

The suspect device was received for analysis, but analysis has not been completed on the device to date.

Event Description

Product analysis was completed on the returned generator.The generator performed as expected with no performance anomalies identified product analysis was completed on the returned lead.The electrode array wasn't received so an evaluation and resulting commentary cannot be made on that portion of the lead.A lead fracture in the negative coil at the point of an abraded opening in the inner and outer tubing was identified.The negative coil had what appeared to be wear (flat surfaces) in the vicinity of the break location.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the cut end of the returned lead portion.A suture was also present constricting the lead, at which point the lead coils were kinked/nicked 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: 7814165
• MDR Text Key: 118254117
• Report Number: 1644487-2018-01484
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2016
• Device Model Number: 304-20
• Device Lot Number: 202017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2012
• 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: 18 YR