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 Ecchymosis (1818); Unspecified Infection (1930)

Event Date 08/05/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.

Event Description

It was reported that the patient underwent vns replacement surgery and that one week post-op, the patient's incision sites looked good.However, a few days later, the patient reported a sudden swelling at the generator site and presented to urgent care, where bactrim was prescribed.The patient then followed up with the implanting surgeon.An incision was made to release drainage and the patient was prescribed cefzil.It was determined that the hematoma needed further treatment and needed to be cleaned out in surgery.The patient underwent surgery to address the hematoma.Upon opening the chest, the surgeon noted pus inside of the lead.It was stated that the surgeon saw "yellow and green" on the lead.It was reported that the impedance values were ok.The surgeon was not comfortable with opening the neck due to the infection.The surgeon planned on removing the generator and a portion of the lead, then tying it down, and waiting for the infection to clear.When attempting to remove a portion of the lead, it was found that a section of the lead further up from the generator appeared to have an opening and they were able to "push stuff out of it".The abraded opening and fluid inside the tubing was reported in mfr.Report #1644487-2019-01885.A review of device history records revealed that the generator was sterilized and passed quality control inspection prior to distribution.The lead was implanted approximately six years prior and, therefore, the sterility of the device post-manufacturing is not relevant.No additional relevant information has been received to date.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9129087
• MDR Text Key: 160780761
• Report Number: 1644487-2019-01886
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/27/2021
• Device Model Number: 1000
• Device Lot Number: 204907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2019
• 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: 42 YR