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

Model Number 1000

Device Problem Mechanical Problem (1384)

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

Event Date 02/18/2020

Event Type  malfunction  

Event Description

It was reported that the patient's device was able to be interrogated but was not able to have the settings changed, a communication error message was received.Information was later received that when the vns was attempted to be programmed or a system diagnostics was attempted, error code 254 was seen.Two different programming systems were used and the error was seen on both.A generator reset was performed and following the reset, a disabled message was seen along with low impedance.The error code messages, disabled message and low impedance after reset can be associated with a reed switch failure.Review of the internal data of the generator indicated that the run state of the device on was "stim inhibited" which can be related to a stuck reed switch.No further relevant information has been received to date.

Event Description

Information was received that the patient underwent generator replacement surgery due to a possible reed switch issue.The explanted generator has been received into analysis however analysis has not been completed to date.No additional relevant information has been received to date.

Event Description

Generator analysis was completed and reviewed.The generator was explanted and returned due to a suspected reed switch issue, with the reed switch being stuck closed.The reed switch closed was not duplicated in the product analysis (pa) lab.When a magnet was applied to the generator multiple times, the reed switch released after removal of the magnet on each occasion.A magnet was applied to the generator for over a minute, and the reed switch opened when the magnet was removed.A cyber magnet was applied to the generator for 60 minutes, and the reed switch released when the magnet was removed.An error code 254 was observed when a magnet was applied to the generator during interrogation.No error codes were noted during normal interrogation.Review of the magnet status indicated 19 magnet holds, 23 magnet swipes, and 42 magnet presences.The generator successfully completed a final electrical test.No functional, mechanical, or visual anomalies were noted with the generator per pa lab.

• 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: 9862993
• MDR Text Key: 188028558
• Report Number: 1644487-2020-00476
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/04/2020
• Device Model Number: 1000
• Device Lot Number: 204553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Event Location: Other
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR