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

Model Number 1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Scarring (2061)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Device return is not needed as the root cause was established to be due to the procedure/user error.(b)(4).

Event Description

It was reported that the patient¿s generator had migrated to his left chest.Physician was concerned that the generator may be pulling on the lead/nerve and is going to order an x-ray as well as shut off the device until a solution can be determined.Additional information was received that the patient's devices were explanted.The physician's office reported that first the plan was to revise the scar and secure the vns so that it was not moving as it appeared to have moved laterally in the chest.The physician believed likely it was not tacked down properly during initial implant.It was then noted the scar site was thin and they noticed it looked like it may open and that the skin integrity was breaking down.The site then did fully open and was pussy so incision needed drainage.Decided to explant the full system due to infection and to allow the site to heal.During surgery the surgeon did not notice any sutures that were securing the generator in place thus was likely the reason for it being freely mobile.The generator was sterilized prior to distribution.No additional relevant information has been received to date.

Event Description

Additional operative notes were received indicating that the patient was admitted for acute left chest wound dehiscence mandating explant of vns generator.Mom has observed excursion of vns generator into left axilla which appears irritating to patient.Generator was noted to be freely migrating.Additionally, generator pocket incision appears hypertrophic with peripheral keloid and central skin thinning uncomplicated incision, drainage, revision and primary wound closure on date of surgery.Lntraoperative tissue swab culture specimen reveals rare gpc resembling staph sp.On gram stain.The patient convalesced unremarkably without change in seizure activity during hospitalization.Aed regimen optimized by neurology to accommodate absence of vns therapy.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11141643
• MDR Text Key: 225837190
• Report Number: 1644487-2021-00047
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/04/2021
• Device Model Number: 1000
• Device Lot Number: 204998
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR