MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 7103; GENERATOR

Model Number 7103

Device Problems Premature Discharge of Battery (1057); Electro-Static Discharge (2149)

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

Event Date 12/14/2022

Event Type  malfunction  

Event Description

It was reported that the patients generator was depleted prematurely.This is reported as possibly related to investigational vns device.Device history records were reviewed for the generator.The generator passed all specifications prior to distribution.The generator was hp sterilized.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 patient's generator is prematurely depleting.It was normal last week at around 80% and it was around 25% a week later.The patient continues to receive dialysis at least once a week.The representative also reported that there actually was no cardioversion or exposure to electrocautery event last fall, and they are unclear what caused his battery depletion.There was no surgery that occurred during this time either.Updated internal generator data was received and reviewed.Based on the data, the generator appears to be prematurely depleting.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was later reported patient did have a medical procedure performed with possible electrocautery and was cardioverted for atrial fibrillation (not alleged against vns).They were told that there was no electrocautery near the device and the pads for the cardioversion were placed appropriately.The representative suspects either of the scenarios could have happened.The most likely scenario is the cardioversion.It was reported that the patient 's generator was programmed back on.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Further review of the data was completed.It was determined that the data lines up with reports of asic latch-up due to electromagnetic induction (emi) or electrostatic discharge (esd) transients leading to premature battery depletion.Once the device is exposed to electrosurgical equipment and the asic is latched, battery voltage displays becomes unreliable.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 7103
• 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: 16117743
• MDR Text Key: 307697149
• Report Number: 1644487-2023-00028
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/14/2023

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: 10/30/2020
• Device Model Number: 7103
• Device Lot Number: 204723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 01/25/2023; 02/21/2023; 03/22/2023
• Supplement Dates FDA Received: 02/08/2023; 03/17/2023; 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2018
• 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
• Patient Age: 75 YR
• Patient Sex: Male