MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 05/20/2021

Event Type  Injury  

Event Description

It was reported that the patient had a hematoma inside the pocket.Operative notes were received and state the patient had a hematoma of left chest wall and hemorrhage at vagal nerve stimulator site.Notes indicate the procedure will include left chest evacuation of hematoma and electronic analysis of vns generator.Notes mention he had vns placed 2 weeks prior and yesterday presented with a hematoma on the chest pocket.The patient indicated that the incision has been healing well without any problems, and he noticed the development of a hematoma approximately a week after the surgery.He denies any pain and denied any drainage from the hematoma.The surgeon attempted accessing the hematoma to see if it was a seroma that could be drained; however, they found, with multiple attempts of sterile drainage, that there was a thick clot in the area.Given that this would not be drained in the office, the surgeon discussed with the patient the concern is that as the hematoma gets processed, it becomes liquid and it increases the pressure in the area, potentially opening the incision and creating an infection.His recommendation was to my evacuate the hematoma immediately.Of note, the patient has an elevated ptt (partial thromboplastin time) that has no known reason.They noted, during the original surgery, that he seemed to bleed more than usual for a procedure of this kind.Notes mention that during the procedure, the surgeon examined the neck area as the initial evaluation of the impedance of the device was in the 3500s and this has increased from the original placement, which was in the 1600s.From his palpation of the neck, the patient may have a small hematoma in the area, which can be causing some of that elevation.The generator was also explored and the suture holding the generator in place was still intact.He proceeded to cut that suture with a 15 blade and very gently removed the generator and the lead from the pocket.The lead and the generator were cleaned.He then proceeded to use suction to remove a thick clot that was present in the area.This clot was coating all the aspects of the pocket.The pocket was then copiously irrigated with saline solution multiple times, removing any clot from that location.He noticed immediately that there was some oozing from the muscle fibers that was quite small, but somewhat consistent.This was also in pattern with the initial injection of local during the surgery, which caused oozing from the skin that was more than the usual for this type of patient.The device was then re-interrogated at the end of the case to make sure that the impedance remained stable.The believed cause of the patient's events are due to patient physiology.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12021590
• MDR Text Key: 257260750
• Report Number: 1644487-2021-00841
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2021

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: 01/12/2023
• Device Model Number: 1000
• Device Lot Number: 6811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR