MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problems Computer Software Problem (1112); Energy Output Problem (1431)

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

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

Internal field number: nm-hou-2019-002.

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.The device was implanted (b)(6) 2019 and therapy was first enabled (b)(6) 2019.Based on a review of the data, the device experienced an initial reset on (b)(6) 2019, consistent with other gc5 events within 60 days of implant.The device was later interrogated on (b)(6) 2019 where the user likely received a message at this time regarding device disablement, and therapy was subsequently re-enabled.Following identification of the device reset and as part of normal procedure, livanova notified the treating physician¿s office in january 2021 that a reset had occurred in this device and planned to schedule a device update.During this notification, the treating physician¿s office notified livanova that the patient had passed away in (b)(6) 2020.The doctor¿s office did not have information on the circumstances or cause of patient¿s death upon inquiry, and no health issues were cited that might point to any potential cause or contribution.Programming data available through (b)(6) 2020 show that no subsequent resets occurred.Based on available data which indicated that the device was functioning as intended through (b)(6) 2020, there is no indication that the device reset caused/contributed to the death, but livanova will continue to investigate this as appropriate and report on any supplemental information received.The device history records of the generator were reviewed.The generator passed final functional and quality specifications prior to release.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 11223400
• MDR Text Key: 229191756
• Report Number: 1644487-2021-00096
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/25/2021
• Device Model Number: 1000
• Device Lot Number: 204911
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2019
• 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: 40 YR