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

Model Number 1000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2019

Event Type  malfunction  

Event Description

It was reported that the septum plug had come out of a generator during a patient's prophylactic battery replacement surgery.It was unknown how many rotations the setscrew was unscrewed, but that it was in accordance with the standard procedure the surgeon had always followed.A backup generator was used in place.The generator was returned for analysis.Analysis has not been completed to date.No additional, relevant information was received to date.

Manufacturer Narrative

Event description, corrected data: initial report inadvertently left out assessment of the device history records.

Event Description

Product analysis was completed for the returned generator.No excessive wear marks were observed on the hex head or the setscrew.No damage was observed on the septum or septum cavity.All dimensions related to the generator septum cavity and septum are within specifications.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.Review of the device history records for the generator showed that the device passed all quality inspections prior to distribution.No additional, relevant information was received to date.

• 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: 8472063
• MDR Text Key: 140592694
• Report Number: 1644487-2019-00631
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Model Number: 1000
• Device Lot Number: 204704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2018
• 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