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

Model Number 1000

Device Problem Energy Output Problem (1431)

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

Event Date 01/17/2021

Event Type  malfunction  

Event Description

It was reported that error code 6 (reset code) was detected on the patient's device with therapy disabled.Therapy was able to be re-enabled and device was found to be functioning within normal limits and providing stimulation again.The device history records of the generator was reviewed.The generator passed final functional tests prior to distribution.The data was reviewed and it was determined that the error code 6 reset occurred 3 days prior to detection.No obvious cause was identified.There were no magnet swipes on this day.No further relevant information has been received to date.

Event Description

It was reported by the health care professional's office that the patient had come in to the appointment where error code 6 was detected because she had stopped feeling stimulation.There was nothing in the notes that indicated anything unusual had occurred prior to the patient stopping feeling stimulation.No further relevant information has been received to date.

Event Description

Internal investigation identified possible causes of the reset.While no conclusive root cause was identified, a comprehensive review of device design identified several potential root causes.These include rare single bit upset corruption events within the device sram, firmware anomalies that could trigger automatic reset of the device under certain circumstances, or transient hardware faults.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
• MDR Report Key: 11287727
• MDR Text Key: 230565738
• Report Number: 1644487-2021-00195
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2021

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: Lay User/Patient
• Device Expiration Date: 04/13/2022
• Device Model Number: 1000
• Device Lot Number: 204743
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 03/09/2021; 10/27/2021
• Supplement Dates FDA Received: 04/01/2021; 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR