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

Model Number 1000

Device Problems Mechanical Problem (1384); Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2018

Event Type  malfunction  

Event Description

It was reported that during a replacement surgery an m1000 generator was unable to be interrogated while still inside the sterile packaging.The same programming system was able to interrogate another m1000 generator.It was later clarified that this occurred in the or.The suspect generator was unable to be interrogated inside the or with the physician's programming system, and was unable to be interrogated outside of the or with three different programming systems.It was reported that the ¿generator not found¿ message was consistently received in all interrogation attempts.It was reported that all the programmers were able to successfully interrogate another demo generator.Also, the programmer used in the or was able to interrogate a generator in the sterile packaging with no changes to the environment (i.E no attempts to reduce electromagnetic interference).A company representative later reported that the suspect generator was able to be interrogated with his own programming system outside of the or, but later was unsure if he was able to interrogate the suspect device or another generator.The generator was not implanted and the facility requested a credit for the device and a report regarding the analysis of the device.A review of device history records for the generator shows that no unresolved non-conformances were found.The device met all specifications for release prior to distribution.The generator has been received, and analysis is underway but has not been completed to date.No additional or relevant information has been received to date.

Event Description

Analysis on the generator was completed.The reported failure to communicate was duplicated in the product analysis (pa) lab.A reset was performed on the generator.The internal memory indicated the microcontroller was fully halted as of (b)(6) 2018 at 9:37 am ct.A cause for the halted microcontroller is unknown.The generator functioned as expected after being reset.No additional or relevant information has been received to date.

Event Description

Further investigation determined that the event was related to a microcontroller manufacturer-related defect that resulted in a lockup of the microcontroller, leading to loss of generator function and communication until a device reset was performed.This could be exacerbated by cold operating temperatures or a high frequency of transitions from low power mode to active mode (device ¿wakeups¿), among other factors.No additional or relevant information has been 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: 8165882
• MDR Text Key: 130386236
• Report Number: 1644487-2018-02298
• 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,Followup
• Report Date: 04/11/2019

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: 06/21/2020
• Device Model Number: 1000
• Device Lot Number: 204545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 02/01/2019; 03/18/2019
• Supplement Dates FDA Received: 02/26/2019; 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2018
• 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