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

Model Number 1000

Device Problem Failure to Interrogate (1332)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  malfunction  

Event Description

It was reported that during a clinic visit, the patient's device was unable to be interrogated despite using a couple of programmers.Multiple angles and wand orientations were used when attempting to interrogate the device.The patient cannot feel stimulation.Implant depth is not suspected to be a contributing factor to the failure to program.X-rays were taken but have not been provided to the manufacturer for review.The patient is scheduled for a battery replacement.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any defects¿ or malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was later reported that a generator reset was attempted without success.When attempting the interrogate the patient, it would not get past 29% complete.The patient could not feel stimulation and the battery was later replaced.The explanted generator has not been received by the manufacturer to date.Internal generator was received and reviewed.No other relevant information has been received to date.

Event Description

Confirmation was later received that all sources of electromagnetic interference (emi) were removed during the interrogation attempt.The generator's log files were reviewed.They confirm that the customer was able to establish communication with the generator, but that the device was unable to make it through a full interrogation.The files indicate that the device would reboot before an interrogation could be completed.Because of the incomplete interrogation, there is not enough meaningful data from the generator to review information such as battery voltage, reboot counter, and reboot reason.No further determinations can be made until the device is received for product analysis.

Event Description

The explanted generator was returned and received by manufacturer to undergo product analysis.Analysis has not been completed 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18453504
• MDR Text Key: 332622376
• Report Number: 1644487-2024-00011
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/17/2024

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: 03/27/2024
• Device Model Number: 1000
• Device Lot Number: 7150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/15/2024; 02/20/2024; 04/24/2024
• Supplement Dates FDA Received: 02/09/2024; 03/15/2024; 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2022
• 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: 16 YR