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

Model Number 1000

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

Internal field number: (b)(4).

Event Description

During an internal data analysis of returned vns therapy programming tablets, a model 1000 device was identified as having experienced a reset, consistent with the issue associated with the gc5 recall.A reset occurred on 8/27/2019 during an office visit and did not result in any significant gaps in therapy delivery (therapy was restored within the office visit).Another reset occurred on 1/6/2020.The device was interrogated on 3/11/20 and likely received a pulse disablement message at that time.There is no evidence of any subsequent resets when interrogated on later dates (most recent available data is from 9/28/21).The device history records of the generator were reviewed.The generator passed final quality and functional specifications prior to release.The generator was manufactured before the screening process was implemented to mitigate the potential for gc5 reboots.No further relevant information has been received to date.Available firmware upgrade has not been completed to date.

Manufacturer Narrative

Internal field number: (b)(4).

Event Description

During an internal data analysis of returned vns therapy programming tablets, a model 1000 device was identified as having experienced a reset, consistent with the issue associated with the gc5 recall.A reset occurred on (b)(6) 2019 during an office visit and did not result in any significant gaps in therapy delivery (therapy was restored within the office visit).Another reset occurred on (b)(6) 2020.The device was interrogated on (b)(6) 2020 and likely received a pulse disablement message at that time.There is no evidence of any subsequent resets when interrogated on later dates (most recent available data is from 9/28/2021).The device history records of the generator were reviewed.The generator passed final quality and functional specifications prior to release.The generator was manufactured before the screening process was implemented to mitigate the potential for gc5 reboots.No further relevant information has been received to date.Available firmware upgrade has not been completed to date.

Event Description

Device was noted to be working properly last time it was checked.No other relevant information has been received to date.

Event Description

Patient had a follow-up appointment to perform gc5 firmware update for the patient's m1000 device.Software update was successfully installed on her device.Database download from tablet was obtained.Settings and diagnostics were both noted to be ok upon initial interrogation of the device prior to the update (no reset had occurred) and were confirmed to be back to intended settings after the update was performed.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 13023547
• MDR Text Key: 285362499
• Report Number: 1644487-2021-01762
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/25/2021
• Device Model Number: 1000
• Device Lot Number: 204855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2019
• 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
• Patient Age: 37 YR
• Patient Sex: Female