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

Model Number	102R
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Convulsion, Clonic (2222); Sleep Dysfunction (2517); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was being referred for battery replacement due to low battery.It was later reported that the patient came back to clinic with a spontaneous change in output current being set to 0ma for unknown reason.No known surgery has occurred to date.No additional relevant information has been received to date.
Event or Problem Description
Additional information was received that the patient is having an increase in seizures related to low battery and is seizing so much that it is interfering with sleep.Clinic notes for the patient were received in which it was indicated that the output current was at 0ma.No known surgery has occurred to date.No additional relevant information has been received to date.
Event or Problem Description
Implant card was received the patient received a replacement due to battery depletion.The hospital the replacement took place does not return explanted products.No additional relevant information has been received to date.
Additional Manufacturer Narrative
B5.Event description - correction - inadvertently did not include the replacement of the battery in the supplemental #01 submitted.D6b.Explant date - correction - inadvertently did not include the explant date of the device in the supplemental #01 submitted.

• Brand Name: PULSE GEN MODEL 102R
• 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: 12196246
• Report Number: 1644487-2021-00978
• Device Sequence Number: 11769377
• Product Code: LYJ
• UDI-Device Identifier: 05425025750023
• UDI-Public: 05425025750023
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2022

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: 01/14/2017
• Device Model Number: 102R
• Device Lot Number: 4266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 11/15/2021; 01/04/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 12/10/2021; 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2015
• 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 Age: 39 YR
• Patient Sex: Female