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

Model Number 1000

Device Problems Premature Discharge of Battery (1057); High impedance (1291); Failure to Interrogate (1332); Defective Component (2292)

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

Event Date 10/26/2022

Event Type  malfunction  

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 reported that a patient's device was unable to be interrogated.The following troubleshooting have been attempted: changing batteries, resetting the programmer and wand, and using another programming system.The location of the generator was verified and implant depth is not a concern.The patient's device was not exposed to electrocautery or electrostatic discharge.Multiple wand angles were attempted.A separate patient was successfully interrogated the same day with the same programming devices.Device history records were reviewed.The device passed all functional specifications and quality tests and were sterilized prior to distribution.No other relevant information has been received to date.

Event Description

Per the representative, a generator reset was attempted, however it is unclear if it was completed due to issues with the programming devices.As a result the patient has been referred for generator replacement.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Additional information was received reporting the device has been explanted and returned for product testing.The device has not been received into product analysis to date.No other relevant information has been received to date.

Event Description

The suspect device was received into product analysis for testing.Product testing has not been completed to date.

Event Description

Product analysis completed testing on the returned generator.No other relevant information has been received to date.

Manufacturer Narrative

H3: device evaluated?, corrected data - in supplemental #04 the initial reporter inadvertently did not select the correct option.Initial reporter should have selected 'yes'.

• 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: 17756806
• MDR Text Key: 323518294
• Report Number: 1644487-2023-01332
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/12/2024

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: 04/11/2024
• Device Model Number: 1000
• Device Lot Number: 7204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 10/10/2023; 12/05/2023; 01/10/2024; 02/08/2024; 04/12/2024
• Supplement Dates FDA Received: 11/03/2023; 12/19/2023; 02/02/2024; 03/04/2024; 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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