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

Model Number 304-20

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2015

Event Type  malfunction  

Event Description

It was reported that the patient is feeling a bulging sensation with stimulation.The vns device was tested and no high impedance was found so the neurologist chose to keep the vns device programmed on.X-rays were taken and it was reported that the electrodes appear dislodged from the nerve.The neurologist believes the electrodes were dislodged because the patient began golfing too soon after surgery.It was also reported that the bulge was not visible from the outside; no protrusion.The patient had lead revision surgery on (b)(6) 2015, the generator was not replaced.After the new lead was implanted and connected to the vns generator, diagnostics were performed and were within acceptable levels.Attempts to obtain additional relevant information have been unsuccessful to date.The explanted generator has not been received to date.It was reported that it was likely discarded by the explanting facility.

Event Description

It was verified that the lead was detached from the nerve.It was also reported that the lead revision surgery resolved the bulging sensation that the patient was feeling previous to the revision.

Event Description

It was later reported through clinic notes the patient experienced widespread muscle spasms in the neck and face prior replacing the lead.

• 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: 4953543
• MDR Text Key: 23218561
• Report Number: 1644487-2015-05198
• 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: Other
• Type of Report: Followup
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Model Number: 304-20
• Device Lot Number: 203056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2014
• 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): Other
• Patient Age: 31 YR