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 09/01/2019

Event Type  malfunction  

Event Description

It was reported that during a replacement surgery a packaged generator could not be interrogated.The following troubleshooting steps were taken but were unsuccessful: tablet was connected to wand via back up cable, tablet was turned off and on, a hard reset was performed on the tablet, a different programming system was attempted.A backup generator was used, and the programming system was able to successfully interrogate other packaged generators.It was noted that the packaged generator was stored in the same location as other generators that were able to be interrogated successfully.Attempts were to interrogate the generator were performed off-site, but were also unsuccessful.Device history records were reviewed for the generator and showed that the device passed all quality inspections prior to distribution.The suspect product was received by the manufacturer, but analysis on the device has not been completed to date.No further 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 lock-up of the microcontroller, which leads to a loss of generator function and communication until a device reset is performed.This potential event could be exacerbated by cold operating temperatures or a high frequency of transitions from low power mode to active mode, among other factors.No further relevant information has been received to date.

Event Description

Product analysis was completed on the returned generator.The reported failure to communicate was duplicated in the pa lab.The crystal oscillator was indicated to not be operating.The generator was reset and normal programming was observed.Review of the data stored in the generator revealed that the date and time for the final electrical test event were incorrect.A review of the internal data of the generator revealed that the failure occurred approximately two months prior to the failure to program event with this generator.The lack of crystal excitation voltage resulted in no crystal oscillation and no communication capability for the generator.The cause for the halted microcontroller is currently unknown.No further 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: 8087586
• MDR Text Key: 127860741
• Report Number: 1644487-2018-02104
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/11/2020
• Device Model Number: 1000
• Device Lot Number: 204561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2018
• 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