MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems False Alarm (1013); Application Program Problem: Parameter Calculation Error (1449); Output below Specifications (3004)

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

Event Date 03/17/2022

Event Type  malfunction  

Event Description

It was reported that a patient has low output current message detected.The device was programmed to 2.25 ma and was noted to possibly not be able to deliver the intended current.A generator at nominal performance would be expected to deliver a minimum of 4.12ma.The minimum output current that the generator is expected to deliver after accounting for normal variations in impedance accuracy and output voltage is 3.12 ma.If the system diagnostic test provides a ¿current delivered¿ value greater than or equal to this value, no device malfunction is present and the generator is operating as expected.Since the current delivered value (2.0 ma) is lower than the minimum expected output current, the generator is potentially not operating as expected.No additional relevant information has been received to date.

Event Description

The previous report of the physician not being able to read the device was mistakenly reported as it was regarding a different patient and the issue resolved.It was reported that at the patient's next appointment in (b)(6) 2022, the current has been restored to normal and all parameters was good.

Manufacturer Narrative

D6a.If implanted, give date (mo/day/yr); corrected information; implant date inadvertently omitted from initial report.

Event Description

It was reported that the physician cannot read the device.No additional relevant information has been received to date.

Event Description

Internal data from the generator was received and reviewed.

• Brand Name: PULSE GEN MODEL 103
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 14077521
• MDR Text Key: 289076700
• Report Number: 1644487-2022-00424
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2023

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: 07/12/2020
• Device Model Number: 103
• Device Lot Number: 204594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 12/10/2022; 01/10/2023; 04/04/2023
• Supplement Dates FDA Received: 01/04/2023; 01/24/2023; 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2018
• 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