MAUDE Adverse Event Report: LIVANOVA USA, INC. PROGRAMMING SOFTWARE

Model Number 250

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem Convulsion, Clonic (2222)

Event Date 10/01/2019

Event Type  malfunction  

Event Description

Was reported that the patient was seen in clinic and had their device checked for the first time since (b)(6) 2019.The doctor noted that the patient's normal mode and magnet mode output currents were both set to 0 ma although the other settings were intact.The neurologist was able to correct the settings.The family reported that the patient's seizures had worsened since 2020.It is known that m102 generator that the patient is implanted with is susceptible to settings changes if diagnostics tests are interrupted (this happens because on m102 generators, diagnostics tests reprogram the patient's settings to run the diagnostic test and then will reprogram the generator, back to intended settings, so if the diagnostics test is interrupted, then settings may not be corrected to intended settings).If a final interrogation prior to ending a programming session to check settings is not performed as recommended, the patient may be left at this settings change.The patient's output current being disabled is consistent with this interrupted diagnostics.The doctor reported that there was no mris (which would require disablement) since the visit.No further relevant information has been received to date.

Event Description

The increased seizures were further described as a marked decline in seizure control with up to 1-3 seizures daily, frequent convulsions, and falls, resulting in emergency room visits and a need to adjust aeds with the addition of a new anti-seizure drug.The patient also moved in with their parents for safety.No further relevant information has been received to date.

Event Description

Further investigation was completed in which it was discovered that an additional report capturing the identical information as outlined in this report was submitted in mfr.Ref# 1644487-2022-00624.As a result no further supplemental reports will be submitted in mfr.Ref# 1644487-2022-00624.All further supplemental information will be submitted within this report.No other relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 12598337
• MDR Text Key: 278128032
• Report Number: 1644487-2021-01385
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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