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 Insufficient Information (4580)

Event Date 08/18/2023

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 the patient was implanted in (b)(6) 2023 and then when their device was checked on (b)(6)n 2023 the battery status showed as 11-25%.The patient was then seen again on (b)(6) 2023 during a hospitalization for unknown reasons, and the battery was noted to be 75-100%.No other relevant information has been received to date.

Event Description

Tablet data was received and reviewed.The battery rebound event was confirmed to be related to a known event cause by the impedance behaviors in the beginning of the battery's life.Internal investigation identified that in some cases, 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.There is no evidence of a device malfunction.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17789055
• MDR Text Key: 323932820
• Report Number: 1644487-2023-01372
• Device Sequence Number: 1
• Product Code: LYJ
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date: 11/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106
• Device Lot Number: 7482
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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): Hospitalization
• Patient Sex: Female