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

Model Number 1000

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

Field number: (b)(4).

Event Description

It was identified that an unscreened m1000 device was distributed to the field on (b)(6) 2019.The manual screening process is part of the quality control processes for this device.While preparing a design history record, the manufacturer observed that the paperwork documenting the manual screening process was not present in the design history record for a m1000 generator.It was identified that this unit should have been screened prior to release but was not.All other m1000 generators that were processed through on the same day underwent the screening, and the unit captured within this report was the only unit that does not have any evidence of a screen occurring.This device was not screened because it was in a rework location.A review of distribution records revealed that the m1000 device was distributed to the field on 08/27/2019.The unit was received at the hospital on 08/28/2019 per the (b)(6) tracking information.The device was successfully removed from the field and was received back to the manufacturer on 10/02/2019.Analysis is underway but has not been completed to date.No other relevant information has been received to date.

Event Description

The generator was returned due to an unscreened device affected by the m1000 device reset field action being distributed into the field.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The generator was subjected to the reboot monitor, gc5 screening test, m1000.The purpose of this screen test is to identify a micro-processor that is susceptible to a potential functional issue within the component which may result in a device reset.The generator passed the screen.There were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 9224416
• MDR Text Key: 166540550
• Report Number: 1644487-2019-02062
• 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
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2021
• Device Model Number: 1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2019
• 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