MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 100; GENERATOR

Model Number 100

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

Patient Problem Pain (1994)

Event Date 01/01/2018

Event Type  Injury  

Event Description

It was reported that this patient underwent explant surgery due to lack of efficacy, the need for an mri and the fact that the device bothers the patient.It was stated that the patient's device was completely dead prior to surgery.The explanted products have not been received by the manufacturer to date.No other relevant information has been received to date.

Event Description

The generator underwent product analysis and an open can measurement of the battery voltage confirmed that the battery was ¿depleted¿.Based on the bench analysis results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion.The device performed according to specifications.Also, diagnostic test results were normal and expected.It was concluded that no abnormal performance or any other type of adverse condition was found with the generator.The lead underwent product analysis and other than typical wear and explant related observations, no other anomalies were identified in the returned lead portion.No further relevant information has been received to date.

Event Description

The explanted lead and generator were received for product analysis.The return product form stated that the device was explanted due to lack of efficacy and the patient needing an mri of their back.Analysis is underway but has not been completed to date.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 100
• 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: 8119963
• MDR Text Key: 128897523
• Report Number: 1644487-2018-02166
• Device Sequence Number: 1
• Product Code: LYJ
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/1999
• Device Model Number: 100
• Device Lot Number: 12197C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/1998
• 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: 46 YR