MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 07/09/2015

Event Type  Injury  

Manufacturer Narrative

Suspect device udi: (b)(4).

Event Description

It was reported that the patient acquired an infection, which was first observed by the physician on (b)(6) 2015.The infection was reported to have started in the chest incision and followed the lead up to the neck site.Patient underwent explant of vns system on (b)(6) 2015 as planned.No patient involvement was suspected.A culture was taken but the results were not available.Review of manufacturing records confirmed that both the generator and lead were sterilized prior to distribution.

Event Description

An image was received showing flushing and puffiness around the generator pocket incision site.Some puffiness was also visible around the neck incision site.Notes from the surgery were also received stating that the patient developed some redness near the incision and some drainage that appears to be infected.The surgeon found some serosanguineous fluid , which was cultured and then removed the generator from pocket.The surgeon also removed the lead and was able to dissect the lead but noted that there was significant amount of scarring and inflammation in the sternoclaoimastoid muscle.

Event Description

Additional information was received that the patient is still fighting (b)(6) infection and that the physician recommended explant of the lead, which was not previously removed.The initial infection was reported to have started about a week after implant.

Event Description

Patient underwent lead removal surgery on (b)(6) 2016 and the surgeon removed the two electrode sets and the anchor tether.During the surgery, the surgeon noted that there was evidence of left vagus nerve injury that resulted in hoarseness and coughing.The surgeon's impression was that someone pulled the lead thinking that the electrodes will unwrap themselves.Per the surgeon, the patient had seen a ent a few weeks ago and received an implant in the left vocal cord to get the vagus nerve to more approximate normal location.

Manufacturer Narrative

Describe event or problem, corrected data: per notes dated (b)(6) 2015, patient was picking at the well healed site and managed to expose of the lead wires.A second surgery to remove the remaining portion of the device was performed as a result on (b)(6) 2015.This information was inadvertently left out of the previously submitted emdrs.

Event Description

Per notes dated (b)(6) 2015, patient was picking at the well healed site and managed to expose of the lead wires.A second surgery to remove the remaining portion of the device was performed as a result on (b)(6) 2015.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5001435
• MDR Text Key: 22897877
• Report Number: 1644487-2015-05491
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Followup,Followup,Followup
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/06/2017
• Device Model Number: 105
• Device Lot Number: 4295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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: 37 YR