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

Model Number 1000

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 07/24/2018

Event Type  malfunction  

Event Description

A company representative reported the she was unable to program a generator in the sterile packaging that was being prepared for implant.When she attempted to apply settings, she observed an error code that indicated that the programming changes could not be applied.She performed troubleshooting to eliminate sources of electromagnetic interference, including moving to the opposite end of the operating room; however, she still could not program the generator.She then used another device of the same model and was able to interrogate the generator without issue.Additional troubleshooting was performed two days later, and the representative was able to interrogate the generator originally intended for implant without issue.The internal data was reviewed for the generator.The data revealed that the generator appeared to be in a magnet-inhibit state during the attempted communications, preventing the generator from accepting and completing any programming commands initiated by the programmer.This resulted in the failure to program the company representative experienced and was the cause of the observed error code.The company representative later reported that the device was not stored near any strong magnet devices.She noted that she wore a watch with a magnetic wristband on both days that she attempted communication with the generator.The device history records were reviewed for the generator.The generator met all functional specifications for release prior to distribution.No additional relevant information has been received to date.

Event Description

The generator was received by the manufacturer for analysis, but analysis has not been approved to date.No additional relevant information has been received to date.

Event Description

Analysis was approved for the generator.No visual anomalies were noted when the generator was removed from the sterile package.The exported programming data was analyzed and found that the generator was in a magnet inhibit state prior to implant.An interrogation test was performed, and diagnostics displayed the expected results.The generator was subjected to and successfully completed electrical testing.No functional anomalies were noted with the generator while it was evaluated during analysis.An internal investigation was performed and determined that the failure to program was likely related to a reed switch that was temporarily stuck in the closed position.It is unclear what may have directly caused the stuck closed reed switch as the exact failure modes could not be replicated during analysis.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7795403
• MDR Text Key: 117576163
• Report Number: 1644487-2018-01433
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2018

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: Other
• Device Expiration Date: 05/16/2020
• Device Model Number: 1000
• Device Lot Number: 204502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 08/17/2018; 09/11/2018
• Supplement Dates FDA Received: 09/11/2018; 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2018
• 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