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

Model Number 103

Device Problem Premature Discharge of Battery (1057)

Patient Problem Depression (2361)

Event Date 04/06/2022

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 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 patients generator battery depleted too quickly.The patient depression is reported to be worsening.Patient has been referred for replacement.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Patient reports getting hiccups every third day and her heart is racing.

Manufacturer Narrative

B2.Outcomes attributed to adverse event; initial mdr inadvertently omitting information known prior to submission.

Event Description

Internal generator data was received and reviewed.Based on the data available, this generator seems 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 had a prophylactic battery replacement the explanted device has not been received to date.No other relevant information has been received to date.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 15439879
• MDR Text Key: 306098164
• Report Number: 1644487-2022-01148
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 00542502575003
• UDI-Public: 0542502575003
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/03/2023

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: 11/16/2019
• Device Model Number: 103
• Device Lot Number: 5550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 11/09/2022; 03/03/2023; 11/07/2023
• Supplement Dates FDA Received: 12/02/2022; 03/18/2023; 12/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2017
• 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): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female