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 Pain (1994); No Code Available (3191)

Event Date 05/06/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr?, device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient¿s generator had migrated inferiorly and was causing the patient pain.The patient underwent repositioning surgery for patient comfort.The surgeon had opened the old incision, pulled the generator up, and added another suture through the suture hole.By adding another suture, it is assumed that the patient's original suture was still present.The patient was later explanted to due lack of efficacy, discomfort, and migration.The patient was suspected of picking at the incision site.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 or relevant information has been received to date.

Event Description

Information was received from the physician.Per the treating physician, the patient's explant was for patient comfort.There was minimal benefit with new generator placement due to an inability to tolerate settings increase due to discomfort.Product analysis was completed for the returned generator.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified in the product analysis lab.In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.No additional or relevant information has been received to date.

• 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: 8822885
• MDR Text Key: 152081849
• Report Number: 1644487-2019-01431
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/06/2020
• Device Model Number: 106
• Device Lot Number: 204415
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2018
• 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: 19 YR