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

Model Number 302-30

Device Problem Corroded (1131)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Tissue Breakdown (2681)

Event Date 02/07/2019

Event Type  malfunction  

Event Description

It was reported that the patient was referred for generator explant due to their generator "eroding" at the site where the lead enters the generator, the header receptacle.The physician indicated that were was evidence of infection in the cervical and chest pockets and that the patient had wound dehiscence through his vns site.The patient was admitted to the hospital and given antibiotics.The patient's vns was removed, cultures were taken, and the infection was reported to have been cleaned out.It was reported that the vns site was "glued and looks great" and that the epileptologist requested to have the vns replacement placed in the patient's left axillae or left back.A review of device history records for the generator shows that no unresolved non-conformances were found.The device met all specifications and was sterilized prior to distribution.The explanted suspect product has not been received to date.No further information has been received to date.

Manufacturer Narrative

Suspect medical device updated to lead all relevant device data corrected.Corrected data: initial report inadvertently reported the generator as the suspect device.Brand name, name of device, model #, serial #, lot #, expiration date, udi, implant date, and manufacture date updated accordingly.

Event Description

The report from the field indicated that the lead had eroded at the connection to the generator, further investigation indicated that was likely referring to the lead pin and not the header of the generator.No further relevant information has been received to date.

Event Description

Information was received from the physician that the patient's infection was present in cervical and generator site and that the cause of the infection may have been due to patient trauma.It was reported that the wound dehiscence was caused by the infection, which was reportedly possibly due to patient trauma.It was indicated that the patient may have picked at the wound.It was also reported that the patient's leads were visibly poking out.The physician indicated that high impedance was not detected on the patient's generator and that both the leads and the generator were explanted due to the infection.No further 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8387619
• MDR Text Key: 137735256
• Report Number: 1644487-2019-00410
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 05/02/2019

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: 01/30/2009
• Device Model Number: 302-30
• Device Lot Number: 1541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 03/04/2019
• Supplement Dates Manufacturer Received: 03/07/2019; 05/02/2019
• Supplement Dates FDA Received: 03/28/2019; 05/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2006
• 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 Outcome(s): Required Intervention
• Patient Age: 36 YR