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

Model Number 1000

Device Problem Communication or Transmission Problem (2896)

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

Event Date 01/13/2020

Event Type  malfunction  

Event Description

It was reported that an un-used/un-opened generator received error code 254 upon interrogation.The generator has been received; however, product analysis has not been completed to date.No other relevant information has been received to date.

Event Description

Product analysis was completed.The failure to program was not duplicated.A results of diagnostic testing indicated the device was operating properly.With the exception of parameters related to the reed switch, results of the final electrical test were successful.Functional bench testing demonstrate that consistent magnet activations are attainable.With the exception of the noted test-related issue, there were no adverse functional, mechanical, or visual issues identified with the returned generator.The error code 254 seen is an expected output for a generator that is disabled (in ¿stop¿ state) when interrogated with v1.6 software.As a functional check at the labeling interrogation step in manufacturing, the devices are interrogated.This interrogation transmits a ¿run¿ command and brings the devices out of the ¿stop¿ state.If this interrogation is missed in manufacturing, the m1000 device will be distributed in a ¿stop¿ state.If the m1000 generator is then interrogated by v1.6 programming software, the user will be warned that the generator is disabled due to a reason ¿254¿ and is not delivering therapy.This is not the case with previous versions of the software, in which the generator will enable upon interrogation and no message will display to the user.Note that this is not a software or generator error, and that the ¿stop¿ state is an acceptable device state.

Event Description

Investigation of the report identified potential root causes.Operator error which inadvertently missed the functional check step in the manufacturing process; lack of alignment between device/programmer design specifications and manufacturing process; inadequate labeling that did not provide appropriate information for the scenario under which the error message (labeling) was displayed to the user.

• 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: 9682025
• MDR Text Key: 184260488
• Report Number: 1644487-2020-00193
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2021
• Device Model Number: 1000
• Device Lot Number: 6522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Event Location: Other
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1