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

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Date 03/25/2015

Event Type  Injury  

Event Description

It was reported on (b)(6) 2015 that the patient had the wound open up at the generator site.The patient¿s generator was recently replaced on (b)(6) 2015.The surgeon was planned to go in and clean the site and sew it back up on (b)(6) 2015.No known patient manipulation or trauma has occurred that is believed to have caused or contributed to the wound opening.The wound opening is not thought to be related to improper wound care from the (b)(6) 2015 surgery.

• Brand Name: PULSE GEN MODEL UNK
• 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: 4805314
• MDR Text Key: 5927151
• Report Number: 1644487-2015-04806
• 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: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• 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: 48 YR