MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problem Unspecified Infection (1930)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy.

Event Description

It was reported by the patient¿s mother that the patient had an infection following their device implant surgery.The infection was cleaned out.The patient picked at their device a few months later and was given antibiotics.The site is now healed without redness or heat.The device history records were reviewed for the generator and lead, and the devices were sterilized prior to distribution.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.No additional information has been received to date.

Event Description

It was reported by the physician that they did not know if the patient's infection was related to picking.No additional information has been received.

• Brand Name: PULSE GEN MODEL 1000
• 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: 8335674
• MDR Text Key: 136025861
• Report Number: 1644487-2019-00272
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2020
• Device Model Number: 1000
• Device Lot Number: 204560
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2018
• 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: 21 YR