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

Model Number 304-20

Device Problems Fracture (1260); High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problem Seizures (2063)

Event Date 11/30/2016

Event Type  malfunction  

Event Description

It was reported that the patient¿s device was not working.It was stated from the office that the patient was doing great after surgery for the 106 and the device was working fine.Then the patient had colon surgery and since that surgery the device has not been working.He is having more break-through seizures.Clinic notes state that the patient was admitted on (b)(6) 2016 and discharged (b)(6) 2016 for a colectomy.The notes do mention that recently he has had increased frequency of minor seizures.The device was interrogated and showed that it is not functioning normally and has high lead impedance.No x-ray shave been taken.No surgical intervention has occurred to date.

Manufacturer Narrative

Describe event or problem, corrected data: the following statement was inadvertently not included in the initial mdr: "it was found that the implant card for the patient's generator indicated that the impedance was within normal limits on date of surgery." relevant tests/laboratory data, including dates , corrected data: the following data was inadvertently excluded in the initial mdr: "(b)(6) 2016: 4390 ohms".

Event Description

It was found that the implant card for the patient's generator indicated that the impedance was within normal limits on date of surgery.The patient underwent lead replacement.It was indicated by the company representative that the generator's impedance was tested with a resistor pin and determined to be within normal limits.The lead pin was also inserted into the generator once and still showed high impedance.The surgeon and company representative did not observe any obvious causes of the high impedance.The suspect lead was reportedly discarded.No further 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: 6183129
• MDR Text Key: 62961125
• Report Number: 1644487-2016-02902
• 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: Initial,Followup
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Model Number: 304-20
• Device Lot Number: 202073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2012
• 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: 42 YR