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

Model Number 1000

Device Problems Failure to Deliver Energy (1211); Physical Resistance/Sticking (4012)

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

Event Date 10/05/2023

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 during a initial implantation procedure high impedance was seen.Pin was cleaned, and then re-inserted.When interrogating the diagnostics was within normal limits.After putting the generator in the chest pocked, interrogation would not fully complete and an error code 254 was seen.Troubleshooting procedures were performed in which the magnet was swiped consecutively for 30 seconds then the device was able to be interrogated.Diagnostics was able to be done three separate times with all good impedance values.The log files were reviewed and it was noted that error code 254 and 128 were seen multiple times during the surgery.Log data provided information that the ipg sensed a magnet presence for the duration of the error message and only when the magnet was not detected anymore, the ipg diagnostics restored.Device history records were reviewed for the device.The device passed all functional specifications and quality tests and was hp sterilized prior to distribution.No other relevant information has been received to date.

Event Description

Additional patient settings and diagnostics were received.It was also noted by the physician that everything is fine and working properly and that the patient has no issues.No other relevant information has been received to date.

Event Description

An additional decoder was created with data from the patient's follow-up clinic visit.No obvious anomalies were found since the date of implant.The most recent decoder shows that as of (b)(6) 2023, there have been 144 magnet swipes and 33 magnet inhibits.This increase in magnet swipe and inhibits counts are not atypical if the patient is an active magnet user.Their physician confirmed that this amount of magnet swipes and inhibitions is an accurate representation of the patient's typical magnet use.The patient's settings have continued to be titrated up, and there are no malfunctions noted since date of implant.It was also noted that the only magnetic field present in the operating room during implantation was from the magnet in the patient essentials kit that is used/ present for troubleshooting the generator.No other relevant information has been received to date.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18030326
• MDR Text Key: 326860050
• Report Number: 1644487-2023-01561
• 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: 03/08/2024

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: Health Professional
• Device Model Number: 1000
• Device Lot Number: 7610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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 Age: 31 YR
• Patient Sex: Female