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); Impaired Healing (2378); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
F10 health effect, clinical code: code e2402 utilized; proposed second level coding - protrusion to capture incidents of a device being visible under the skin.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
It was reported that in pre-op for a surgery unrelated to vns therapy, the hospital staff noticed a quarter-sized scab on the patient¿s chest.The surgeon offered to open and clean the scab since the patient would already be anesthetized.After this procedure, the patient¿s mother noticed the wound was not healing properly, so the patient was taken to a wound care specialist.They advised bandages and activated charcoal.After using these bandages, patient¿s mother noticed leads were protruding near where the wound that had been cleaned.Patient is scheduled for surgery to re-open, debride, wash, and close the wound and check the lead integrity.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
It was later reported that the patient was scheduled for system removal due to wound dehiscence.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
The patient's physician later reported that the cause of wound dehiscence was foreign body response.No other relevant information has been received to date.

• 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: 18912752
• Report Number: 1644487-2024-00302
• Device Sequence Number: 6759820
• Product Code: LYJ
• UDI-Device Identifier: 05425025750528
• UDI-Public: 05425025750528
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2024

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: 04/23/2025
• Device Model Number: 1000-D
• Device Lot Number: 785
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 04/01/2024; 05/09/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/26/2024; 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• 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: Other
• Patient Age: 45 YR
• Patient Sex: Male