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

Model Number 304-20

Device Problems Fluid/Blood Leak (1250); High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Neck Pain (2433)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient starting experiencing pain in the neck and jaw 1-2 weeks prior to the date of this report.The treating physician reprogrammed the generator to attempt to help alleviate the pain, but the pain did not resolve.No contributing trauma had occurred prior to the experience of pain.The patient has taped the vns magnet over the generator site to inhibit stimulation, which resolved the pain.The patient underwent surgery on (b)(6) 2016 due to the report of the pain.Lead impedance prior to the case was approximately 4000 ohms.The surgeon observed fluid in the lead, and the lead was replaced at that time.No obvious points of entry in the lead were visualized at the time of surgery.It could not be distinguished if the fluid bubbles were in contact with the lead wire.The impedance following lead replacement was 1684 ohms.The explanting facility will not return products to the manufacturer.Therefore, product return attempts could not be completed.The lead device history record was reviewed, and it was found that all specifications were met prior to distribution.Attempts for additional pertinent information have been unsuccessful to date.

Event Description

It was reported that the patient was doing well following the surgery to replace the implanted lead.Programming data related to the patient¿s vns system at the time of surgery was received and reviewed.The first interrogation showed that the last automatic impedance check was registered at 3342 ohms at 12:45pm on (b)(6) 2016.The subsequent system diagnostic performed resulted in 4027 ohms.After the lead was replaced, the next system diagnostic registered 1685 ohms.No anomalies in the impedance were noted in the internal device data.No additional pertinent information has been received 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: 6029911
• MDR Text Key: 57577699
• Report Number: 1644487-2016-02366
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: 304-20
• Device Lot Number: 203485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2015
• 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: 27 YR