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

Model Number 1000

Device Problem Over-Sensing (1438)

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

Event Date 03/21/2018

Event Type  malfunction  

Event Description

During an implant procedure, it was reported that the generator's heartbeat detection feature was consistently sensing twice the patient's heart-rate.Various heartbeat detection sensitivity levels were tried, but these did not resolve the issue.System diagnostics and settings were reported to be normal.A review of device history records for the generator shows that no unresolved non-conformances were found and the device met all specifications for release prior to distribution.No additional or relevant information has been received to date.

Event Description

Information was received that ekg data was reviewed by the neurologist, and it was found that the patient had an abnormal heart rhythm with an elevated t-wave.The neurologist believes this may be related to the reported oversensing.Also, a pre-surgical evaluation was not performed to determine the proper location of generator implant for optimal tachycardia detection.No additional or relevant information has been received to date.

Event Description

The internal data from the generator was reviewed.It was found that the device was consistently sensing a heart rate that was double the reported ekg heart rate.It was also found that only one heart rate sensitivity setting was used during implant surgery.No additional or 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
• 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: 7430532
• MDR Text Key: 105527945
• Report Number: 1644487-2018-00575
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/13/2019
• Device Model Number: 1000
• Device Lot Number: 204236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 0 YR
• Event Location: Other
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2017
• 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: 10 YR