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

Model Number 304-30

Device Problem Moisture or Humidity Problem (2986)

Patient Problems Fall (1848); Pain (1994)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported experiencing painful stimulation when he turned his head to the left.The painful stimulation progressed to caused the patient to fall to the floor.The patient then had revision surgery on (b)(6) 2016.During surgery there was visible fluid inside the lead casing observed by the surgeon.There were no observed abraded openings or beaks in the lead.The patient's lead was removed.The lead was then discarded by the facility.The physician stated that the patient is a very violent patient and the patient's seizures may have contributed to the event.No high impedance was observed prior to the surgery.No other relevant information has been received.

Manufacturer Narrative

Outcomes attributed to adverse event, corrected data: initial mdr inadvertently checked an outcome; however, there was no reportable adverse event so there was no outcome.Date of event, corrected data: initial mdr inadvertently included a date that did not best represent the time of the event.

Event Description

Clinic notes received indicate that the patient had a fall in (b)(6) 2016 and afterwards the patient reported being electrocuted from his vns.It was noted that the tingling and numbness worsened when the patient turned his head to the left.The physician then attempted to lower the patient's settings to mitigate the pain however it did not resolve and the patient was referred to the previously reported surgery.Diagnostics were within normal limits as of (b)(6) 2016.

• 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: 6142022
• MDR Text Key: 61701173
• Report Number: 1644487-2016-02761
• 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,Followup
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/21/2018
• Device Model Number: 304-30
• Device Lot Number: 4130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2014
• 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: 56 YR