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

Model Number 105

Device Problem Extrusion (2934)

Patient Problem Scarring (2061)

Event Date 07/22/2014

Event Type  Injury  

Event Description

It was reported that the recently implanted vns patient underwent surgery on (b)(6) 2014 to explant his generator and lead.The patient had been scratching at his cervical wound site which subsequently led to extrusion of the electrode.It was noted that the patient had a history of combativeness, aggressiveness, and self-mutilating behavior.The patient went to the er where approximately 6cm of the patient¿s lead was found to be visibly extruding from the approximate 6mm opening of the patient¿s wound.There was no purulence but the patient was sent for surgery due to risk of infection.During explant, granulation tissue was found at the area of dehiscence and a significant amount of scarring was noted within the patient¿s neck.The extruding portion of the patient¿s lead was cut and discarded.Samples were taken for cultures and the patient¿s wound was cleaned and irrigated.The patient has not been re-implanted to date.

• 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: 4131361
• MDR Text Key: 18032506
• Report Number: 1644487-2014-02524
• 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: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: 105
• Device Lot Number: 202828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2014
• 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: 9 YR