MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Premature Discharge of Battery (1057); Premature Elective Replacement Indicator (1483); Battery Problem: High Impedance (2947)

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

Event Date 12/29/2021

Event Type  malfunction  

Event Description

It was reported that the patients battery depleted more quickly than expected.The device history records of the generator were reviewed.The generator passed final quality and functional specifications prior to release.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

Per further review of the file, based on the available information, the event can be concluded to likely be caused by a known event in which pulse generators reach the 25% battery indicator earlier than expected, and later rebound to 75-100% without any significant programming changes.This behavior was determined to be due to an increased duration of high battery impedance during generator battery beginning-of-life.M106 generator batteries exhibit a low battery voltage reading behaviors at the beginning of the battery¿s life, due to well-understood battery impedance behaviors of the generator batteries.The battery voltage rebounds when approximately 4% to 5% of the initial battery is consumed for most generators.Due to this known behavior, the generator has a built-in 0.5v offset added during the first 7.5% of the battery consumption to mitigate the potential for artificially low voltage measurements during this period.This offset is then removed once 7.5% of the initial battery is consumed.In a few cases, the beginning of life impedance behaviors may extend past the 7.5% consumption point, which can result in a temporary low battery status.When the behavior extends past 7.5% battery consumption, this is not an indication of a device failure, but rather an outlier in the expected timeline of the battery voltage drop.In these cases, the generator battery is expected to re-bound and will exhibit normal battery depletion timelines.Based on the previous data review that was reported, this event appears to be consistent with the investigation described above and the patient's battery status will likely rebound.Battery rebound has not been confirmed to date.No further relevant information has been received to date.

Manufacturer Narrative

B5: corrected data, initial report.Inadvertently did not include information about the beginning of life high battery impedance which can lead to a battery rebound event.F10: corrected data, initial report.Inadvertently used the incorrect medical device codes h6: corrected data, initial report.Inadvertently used the incorrect codes for findings and conclusions.

Event Description

It was confirmed that the battery status rebounded.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 13319233
• MDR Text Key: 284354674
• Report Number: 1644487-2022-00064
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/11/2021
• Device Model Number: 106
• Device Lot Number: 6379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2019
• 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 Sex: Male