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

Model Number 304-20

Device Problem Fracture (1260)

Patient Problems Chest Pain (1776); Seizures (2063); Neck Pain (2433)

Event Date 08/09/2018

Event Type  malfunction  

Event Description

It was reported that a patient¿s device is showing high impedance.It was reported the patient's seizure activity has increased and she sometimes feels a "zap" in her neck or chest.It was reported that her (b)(6) head-butted her in the chest.The patient was sent for an x-ray of the neck and chest however there were no lead breaks observed.No known surgical intervention has occurred to date.No additional or relevant information has been received to date.

Event Description

The patient had a lead replacement surgery.The explanted device has not been received for analysis to date.

Event Description

Product analysis on the lead was completed and approved.The lead was returned due to lead fracture, lead break, and high impedance.The analysis did not confirm a discontinuity in the returned portion of the device which may have contributed to the stated allegation.A significant portion of the lead (including the electrode array) was not returned for analysis, therefore an evaluation and resulting commentary cannot be made on that portion of the lead.Sets of setscrew marks were seen on the marked connector pin providing evidence that proper contact between the setscrew and the marked connector pin existed at least once.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.

Event Description

The lead was received for analysis.Analysis is currently underway.Additional information was received that the surgeon did reinsert the pin two different times prior to the lead revision and lead impedance was still high after both times.He verified that the lead was pushed past the second connector block.No additional or 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: 7826426
• MDR Text Key: 118553893
• Report Number: 1644487-2018-01517
• 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,Followup
• Report Date: 12/11/2018

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: 07/31/2018
• Device Model Number: 304-20
• Device Lot Number: 203022
• 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
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 09/07/2018; 10/27/2018; 11/29/2018
• Supplement Dates FDA Received: 10/02/2018; 11/20/2018; 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2014
• 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): Other
• Patient Age: 48 YR