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

Model Number 1000

Device Problems High impedance (1291); Detachment of Device or Device Component (2907); Incomplete or Inadequate Connection (4037)

Patient Problem Convulsion, Clonic (2222)

Event Date 11/02/2023

Event Type  malfunction  

Event Description

It was reported that high impedance was seen upon interrogation of the patients device additional information was received noting that the patient has been experiencing an increase in seizures.Upon interrogation of the device by the physician, output current low was found and the device was not able to deliver full programmed settings due to the high impedance.Device was noted to then be disabled and patient was referred for surgery.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 livanovas 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.

Manufacturer Narrative

B6.Relevant tests/laboratory data; corrected data; initial mdr inadvertently omitted known information prior to submission.

Event Description

Additional information was received noting that during surgery the surgeon observed that the pin was not fully inserted in the generator.When the surgeon was loosening the setscrew, the screw completely fell out.Battery was then replaced and device was within normal limits.It was noted that per reported details of the event the likely cause of the high impedance condition would have been due to the lead pin not being fully inserted in the header cavity and the set screw not having proper contact with the pin.The note of the setscrew falling out of the septum when the surgeon was loosening the setscrew to re-insert the pin and tighten the setscrew for verification.When setscrew popped out the surgeon elected to replace the generator.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.

• 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: 18336222
• MDR Text Key: 331053734
• Report Number: 1644487-2023-01800
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1000
• Device Lot Number: 5160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• 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): Other
• Patient Age: 25 YR
• Patient Sex: Male