MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Unspecified Infection (1930); Tissue Damage (2104); Tissue Breakdown (2681)

Event Date 10/03/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the infection, extrusion and tissue damage, is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that this patient recently had a generator replacement, and then explanted due to infection.It was stated that the patient wears a vest for circulation over his chest area the vest was most likely rubbing on the patient's chest, rubbed the incision open, and caused the infection as well as the generator to come out of the patient's skin.Operation notes were received that stated that the leads were removed, but the portion of the leads that encircled the vagus nerve were left in place as it was too densely scarred and taking them out would probably injure the nerve.There was no infection in this area at all.Once the leads were taken out, the wound was irrigated vigorously and closed.The generator pocket was opened and cultures were taken.Gross purulence was found and the generator was removed.There was some brownish tissue and some necrotic tissue that was debrided from the chest wall with a knife.No other abscess pockets or tunneling was found anywhere else.This pocket was irrigated thoroughly and a dressing was applied.A review of device history records showed that the implanted generator and lead were sterilized prior to distribution.All other quality tests also passed prior to distribution.No other relevant information has been received to date.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.

Manufacturer Narrative

(b)(4).

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• 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: 8162357
• MDR Text Key: 130308630
• Report Number: 1644487-2018-02289
• 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
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/21/2020
• Device Model Number: 106
• Device Lot Number: 5641
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2018
• 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: 20 YR