MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL UNKNOWN

Device Problem Human-Device Interface Problem (2949)

Patient Problems Wound Dehiscence (1154); Twiddlers Syndrome (2114)

Event Date 05/01/2015

Event Type  Injury  

Event Description

It was reported that the patient had picked at the neck incision site and pulled out the leads.Patient managed to pick open his neck incision and was seen on (b)(6) 2015.The physician was able to see some of suture underneath the and determined it best to explant the device as patient might end up pulling out a portion of the vns with a risk of infection.Patient underwent full explant on (b)(6) 2015.Additional information was received that the patient previously picked the chest incision site causing wound dehiscence.This is reported in manufacturer report # 1644487-2015-04803.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• 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: 4803482
• MDR Text Key: 5830953
• Report Number: 1644487-2015-04804
• 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: Physician
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 23 YR