MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number	102
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician has had two incidents where he performed testing on a patient's device and then performed a final interrogation to confirm the patient was programmed to intended settings, but at the next appointment the settings had spontaneously changed.This mdr captures the report for one unknown patient, mfr.Ref # 1644487-2022-00624 captures the report for the other.No additional or relevant information has been received to date.
Event or Problem Description
It was reported that no true malfunction had occurred.Tablet data was received in which it was confirmed that no final interrogation was performed.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Common Device Name: 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: 14519158
• Report Number: 1644487-2022-00609
• Device Sequence Number: 12369261
• Product Code: LYJ
• UDI-Device Identifier: 05425025750016
• UDI-Public: 05425025750016
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/17/2016
• Device Model Number: 102
• Device Lot Number: 203017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown