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

Model Number 1000

Device Problems Failure to Deliver Energy (1211); Physical Resistance/Sticking (4012)

Patient Problem Vomiting (2144)

Event Date 07/07/2023

Event Type  malfunction  

Event Description

It was reported that the patient has experienced an increase in vomiting.The patients device showed error warnings regarding the output status and low impedance.Impedance readings were different after consecutive checks.Two different programming systems were used to interrogate the patient.The device was turned off.The device history records of the generator were reviewed.The generator passed final quality and functional specifications prior to release.Internal generator data was received and reviewed.The data was consistent with that of a stuck reed switch malfunction.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 the generator was unable to be reset.Successive magnet swipes were later attempted in clinic to unstick; the reedswitch, but they were not successful.There are no clinical symptoms related to loss of therapy.The device can be interrogated (showing low lead impedance), but the patient cannot be programmed.

Event Description

It was later reported that the patient underwent a battery replacement.The explanted battery has not been received by the manufacturer to date.

Event Description

The generator was received by the 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: 17514762
• MDR Text Key: 321107015
• Report Number: 1644487-2023-01108
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/11/2024
• Device Model Number: 1000
• Device Lot Number: 578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 08/24/2023; 11/14/2023; 12/11/2023; 03/04/2024
• Supplement Dates FDA Received: 09/18/2023; 12/08/2023; 01/05/2024; 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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 Outcome(s): Other
• Patient Age: 12 YR
• Patient Sex: Male