MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem Device Slipped (1584)

Patient Problems Granuloma (1876); Unspecified Infection (1930)

Event Date 08/26/2015

Event Type  Injury  

Event Description

It was reported that the patient has an infected lead.The manufacturing record for the lead was reviewed and sterilization was confirmed prior to shipment.The patient underwent surgery on (b)(6) 2015 and it was found that a loose tie-down was causing the perpetual wound infection.The physician noted that this was the second time it was loose.The vns remains implanted and there was no infection down inside the wire.The tie-down was loose causing a granuloma.Additional information has been requested but no further information has been received to date.

Event Description

The physician later reported that she is not aware of any patient manipulation or trauma that is believed to have caused or contributed to the tie-down becoming loose.

Event Description

It was reported on (b)(6) 2015 that the patient's incision site is still showing signs of infection.It is unknown what treatment plan the patient will undergo at this time.

Event Description

It was reported that the patient was scheduled for explant due to the infection.The vns was removed on (b)(6) 2015.

Event Description

The physician reported that only the generator was explanted on (b)(6) 2015.

Event Description

On (b)(6) 2016 it was reported that the patient's lead would be explanted as well.Although surgery is likely, it has not occurred to date.

• Brand Name: LEAD MODEL 304
• 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: 5090558
• MDR Text Key: 26268962
• Report Number: 1644487-2015-05842
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Followup,Followup,Followup,Followup
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Model Number: 304-20
• Device Lot Number: 3888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2014
• 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: 8 YR