MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302; GENERATOR

Model Number 302-20

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Seroma (2069)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

It was reported that the patient's generator incision had approximately a 1 cm opening.The patient was taken to surgery to where the incision cleaned and closed.The generator was left implanted.Review of the manufacturing records confirmed that the generator was sterilized and passed quality control inspection prior to distribution.It was noted that a few months prior to this report the generator had been repositioned due to infection.This event was reported in mfg report #1644487-2016-02673 however with the information available it does not appear that the current dehiscence wound is related to the previous infection.No additional relevant information has been received to date.

Event Description

It was reported that the generator pocket began filling up with fluid shortly after surgery that addressed the dehiscence wound.The fluid appeared to be building up behind the generator and the generator appeared to be "floating" in the pocket due the fluid.The patient was referred for surgery to drain the pocket and explant the generator.During the operation the surgeon observed that there was fluid inside the lead.Diagnostic testing was performed prior to surgery and there were no issues observed with the lead impedance.The surgeon was concerned that the fluid leaks in the lead could have been a contributing factor for the infection issues that were previously reported in this report and in mfg report #1644487-2016-02673.Manufacturing records were reviewed for the lead it was confirmed that the lead was sterilized prior to distribution.The lead and generator were both explanted at that time.Historically, the explanting facility does not return explanted products to manufacturers.Therefore product return is not expected.This report will continue to capture the fluid leaks in the lead and dehiscence wound events while g report #1644487-2016-02673 will capture the initial infection that occurred after the generator replacement surgery.

• Brand Name: LEAD MODEL 302
• 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: 6324817
• MDR Text Key: 67206933
• Report Number: 1644487-2017-03189
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2004
• Device Model Number: 302-20
• Device Lot Number: 7416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2002
• 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: 30 YR