MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problems Therapeutic or Diagnostic Output Failure (3023); No Apparent Adverse Event (3189)

Patient Problem Discomfort (2330)

Event Date 01/06/2023

Event Type  malfunction  

Event Description

It was reported that during a battery replacement surgery, a generator¿s settings were incorrect following intraoperative programming.This issue was noted to be resolved during surgery.It was later reported that in patient¿s follow-up clinic visit, they had been in pain since replacement surgery.When the device was interrogated, its parameters were higher than previously set in surgery.The nurse practitioner lowered the settings again and patient appeared to be feeling better.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

Internal generator data was reviewed from the received tablet data contained programming history from the day of implant.The data does not indicate that the patient was ever programmed to the alleged 2.25ma.The patient was intentionally programmed to 2.75ma during surgery; therefore there was no spontaneous change in settings.The company representative incorrectly put in the settings; therefore, there was no device malfunction.

Manufacturer Narrative

B1.Corrected adverse event determination, initial report: inadvertently did not select adverse event in addition to malfunction b2.Corrected adverse event outcome, initial report: inadvertently did not select outcome attributed to adverse event.

• Brand Name: PULSE GEN MODEL 1000
• 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: 16417865
• MDR Text Key: 310171829
• Report Number: 1644487-2023-00218
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

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: 05/02/2024
• Device Model Number: 1000
• Device Lot Number: 205818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• 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): Other
• Patient Age: 18 YR
• Patient Sex: Male