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

Model Number 304-20

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problems Seizures (2063); No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2017

Event Type  malfunction  

Event Description

It was reported that a neurologist observed high impedance on a patient's device during a clinic visit.The neurologist reported that high impedance was not observed during the previous clinic visit (b)(6) prior.The patient's family also reported that she had fallen during her seizures.The patient was referred for surgery.No additional relevant information has been provided to date.No surgical intervention has occurred to date.

Event Description

The patient's father reported that the patient was experiencing an increase in seizures due to the high impedance.According to the patient's father, the surgeon believed that the lead may have become dislodged from the patient's vagus nerve.The patient underwent full revision surgery.The surgeon and company representative confirmed that the electrode had become dislodged from the nerve, but the surgeon did not know what caused the electrode to come off of the nerve.The explanted lead and generator were discarded and are unavailable for analysis.No additional relevant 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: 6586456
• MDR Text Key: 75816390
• Report Number: 1644487-2017-03865
• 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: 06/27/2017

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: 05/31/2018
• Device Model Number: 304-20
• Device Lot Number: 202923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2014
• 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: 29 YR