MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problems Degraded (1153); Material Protrusion/Extrusion (2979)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 10/20/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, it was reported that the patient¿s vns is protruding out of her skin and about 40% of it is exposed.There were clear signs of infection; swelling with yellow pus and is sensitive at the incision line but not surrounding areas.The patient¿s mother reported that it has been like this for 2-3 weeks and initially they covered it with a band-aid but it is now too painful to cover.The patient was referred to the surgeon.The surgeon stated that the patient scratched out her vns, which is why it is coming out through the chest and not at the original incision site.He admitted her to remove the unit and the lead wires due to infection.The surgeon removed the device on (b)(6) 2014 and noted there were no plans to re-implant as the patient had scratched the device out.

• Brand Name: PULSE GEN MODEL 104
• 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: 4285570
• MDR Text Key: 5300255
• Report Number: 1644487-2014-03169
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2015
• Device Model Number: 104
• Device Lot Number: 3682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2013
• 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): Other
• Patient Age: 56 YR