MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problems Fracture (1260); Low impedance (2285); Malposition of Device (2616)

Patient Problems Chest Pain (1776); Inflammation (1932); Scarring (2061); Neck Pain (2433)

Event Date 10/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The mdr with manufacturing number 1644487-2016-02598houses the reports of chest pain and device repositioning.The patient reported experiencing neck pain associated with stimulation.The device was then disabled.The patient's surgeon elected to perform an exploratory surgery.During a pre-operative system diagnostics test the patient had severe pain at their neck and it was decided that the exploratory surgery would open the neck incision.The surgeon opened the neck incision and found scarring and inflammation present.The surgeon then dissected the lead and discovered that the electrodes were placed on the wrong nerve.A tension lead fracture was also observed.The lead was then removed and a new lead was inserted.A significant drop in lead impedance was observed from 3944 ohms to 1208 ohms once the new lead was placed on the nerve and connected to the generator the explanting facility disposed of the explanted lead and thus no product return is expected.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6122152
• MDR Text Key: 60934987
• Report Number: 1644487-2016-02688
• 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: Patient
• Type of Report: Initial
• Report Date: 11/04/2016

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: 02/29/2020
• Device Model Number: 304-20
• Device Lot Number: 203718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• 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: 46 YR