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 Convulsion, Clonic (2222)

Event Date 01/08/2024

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

Patient presents into clinic with reports of decreased perception of stimulation and an increase in seizures.Upon interrogation it was noted that low output current was observed with impedance value being ok.A system diagnostics was noted to be attempted but failed with error code 128 and 254.Troubleshooting was performed in decreasing emi, wand positioning, and wand/tablet reset which did not resolve the issue.Magnet was swiped consecutively and rapidly for 20-30 seconds which also did not resolve the issue.Events and trends noted that the last magnet swipes that were recorded were on january 8 and no swipes that were made today were recorded.Generator reset was performed with an initial error code 4 (due to the generator reset performed) and low impedance was seen.Internal generator data was reviewed and appears that the cause of this issue is a potential reed switch being stuck.No other relevant information has been received to date.

Event Description

Additional information received noting that the patient has been swiping their magnet but no magnet swipe timestamps were seen upon interrogation of the device.The patient then later underwent surgery to have their generator replaced.The explanted generator has not been received by product analysis to date.

Event Description

Additional information received noting that the suspect device was misplaced and is no longer available for return.

• 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: 18790178
• MDR Text Key: 337459773
• Report Number: 1644487-2024-00213
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000
• Device Lot Number: 206085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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: 48 YR
• Patient Sex: Female