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

Model Number 304-20

Device Problems Fracture (1260); High impedance (1291)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/13/2017

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2017 that the patient had high impedance.Her device was disabled.Clinic notes reported that the patient felt that the magnet wasn't working as the magnet swipes didn't make her cough like typically had before.No known surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

The patient underwent full revision surgery due to the high impedance.During explant of the lead, the surgeon noted that the patient's lead was not attached to the vagus nerve.All parts of the lead were anterior to the carotid artery.The surgeon said that the electrodes were around 0.5 inches away from the vagus nerve.The suspect device has not been received to date.No further relevant information has been received to date.

Event Description

The patient's lead and generator were received into product analysis.Pa was completed on the returned lead.The lead was returned in 3 portions without tie-downs.Set screw marks were observed on the lead pin, indicating that at one point in time, there was a good electromechanical connection between the lead and generator.The condition of the returned lead portions was consistent with those that typically exist following an explant procedure.No obvious anomalies were noted.Continuity checks of the returned lead portions were performed during the visual analysis, and no discontinuities were identified.Product analysis was completed on the returned generator.The generator was monitored in a simulated body-temperature environment for over 24 hours.The generator provided the expected output current for the entirety of the monitoring period.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrated that accurate resistance measurements were obtained in all instances.The generator performed according to functional specifications with no anomalies found.The surgeon and the treating physician indicated that they didn't know what caused the patient's electrode to migrate off the nerve.The treating physician did not know of any trauma to the neck site.No further relevant information has been received to date.

Manufacturer Narrative

Supplemental mdr 1-- describe event or problem, corrected data:supplemental mdr 1 inadvertently reported that the suspect product hadn't been received instead of "the suspect lead and the generator were received and pending completion of product analysis." supplemental mdr 1-- device available for evaluation?, corrected data: supplemental mdr 1 inadvertently reported that the patient's product had not been received.However, prior to submission the mdr the product was received on 08/31/2017.Supplemental mdr 2-- date received by manufacturer (mo/day/yr), corrected data: supplemental mdr 2 inadvertently reported 08/31/2017 as the aware date instead of 09/13/2017.

• 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: 6694894
• MDR Text Key: 79394038
• Report Number: 1644487-2017-04111
• 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,Followup,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2016
• Device Model Number: 304-20
• Device Lot Number: 3316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2012
• 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 Age: 55 YR