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

Model Number	1000-D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Post Operative Wound Infection (2446)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient has been referred for explant due to an infection and wound dehiscence.Additional information was received confirming that the patient's generator was explanted due to the infection and wound dehiscence.Device history records were reviewed for the generator.The device passed all functional specifications and quality tests and were sterilized prior to distribution.Device evaluation is not necessary because the reported event has been determined to be related to the implant procedure.No other relevant information has been received to date.
Additional Manufacturer Narrative
H3.Device evaluated by mfr? code 81 - device evaluation is not necessary because the reported event has been determined as not related to the functionality or delivery of therapy of the device.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 or Problem Description
Additional information was received from the physician.Per the physician, the wound dehiscence and infection were first seen on (b)(6) 2024.It was determined that no infection was actually present.The wound dehiscence was seen over the generator site, and the cause was not determined, but it was noted that the patient is being scheduled for a follow-up with plastic surgery for further evaluation.The physician also confirmed only the generator was explanted.No other relevant information has been received to date.
Additional Manufacturer Narrative
B3 date of event, corrected data: initial report inadvertently listed incorrect event date.B5 describe event or problem, corrected data: additional information received from the physician was inadvertently omitted from initial report.F10 health effect - clinical code, corrected data: initial report incorrectly utilized code e2115.H6 type of investigation, corrected data: initial report incorrectly utilized code b11.H6 investigation conclusions, corrected data: initial report incorrectly utilized codes d1002 and d12.

• Brand Name: PULSE GEN MODEL 1000-D
• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 20694333
• Report Number: 1644487-2024-01426
• Device Sequence Number: 3850921
• Product Code: LYJ
• UDI-Device Identifier: 05425025750528
• UDI-Public: 05425025750528
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/18/2026
• Device Model Number: 1000-D
• Device Lot Number: 206340
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female