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

Model Number 304-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Seroma (2069); No Code Available (3191)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the reported events were not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient had an abscess in their neck and that their lead was exposed.The patient was hospitalized for a neurosurgery evaluation and referred for a possible lead revision.It was reported that the physician assessed that the patient was no longer infected.Device history records indicated that both the lead and generator were sterilized per specifications and passed all quality tests prior to distribution.Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

The patient's generator and lead were explanted.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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8613778
• MDR Text Key: 145206768
• Report Number: 1644487-2019-00933
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/05/2021
• Device Model Number: 304-20
• Device Lot Number: 204224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2017
• 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: 60 YR