MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Seizures (2063)

Event Date 10/01/2014

Event Type  Injury  

Event Description

Additional information was received that the patient has an abscess on the left side of his throat which is pressing on the vocal cord and could lead to vocal cord paralysis.A neck and chest ct was performed which showed that a part of the vns leads and a tie down were not explanted previously.The physician believes that the presence of the device may be contributing to an infection.Patient is scheduled to have the abscess drained.Attempts for additional relevant information were unsuccessful.

Event Description

Additional information was received that the patient underwent surgery.During the surgery, the physician noted that the entire vns lead and tie-downs were not previously removed.The physician also noted scar tissue formation around one of the arteries leading to the brain with a 50% chance of a stroke.

Event Description

Additional information was received that the patient continues to have voice hoarseness that is better in the morning but worsens as they day progresses.According to the ent physician, the patient may need another surgery if patient's voice does not improve.

Event Description

Additional information was received that the patient continues to have voice issues and that the patient plans to have surgery to address this.Patient's seizures were reported to be under control.

Event Description

Additional information was received that the patient underwent explant of the vns generator and lead on (b)(6) 2014.

Event Description

It was reported that the vns patient was seen by a dermatologist due to a pimple on the patient¿s neck.The dermatologist removed the pimple and also pulled out what appeared to be a surgical staple from under the patient¿s skin.Subsequently, the patient¿s lead was extruding under the patient¿s skin and the patient began experiencing pain at the lead site.The patient¿s device was tested and diagnostic results showed normal device function.The patient was referred for surgery but no know surgical interventions have occurred to date.

Event Description

Additional information was received that the patient's voice is normal and that the patient is better currently.

Manufacturer Narrative

Date received by manufacturer (mo/day/yr), corrected data: 09/08/2015.The previous supplemental mdr #7 incorrectly lists the aware date as 08/04/2015.The correct aware date is 09/08/2015.

Event Description

Additional information was received that the patient will be undergoing another vocal cord surgery on (b)(6) 2015.Per the ent, the portion of the lead that was left implanted at the time of generator explant caused vocal cord infection, resulting in vocal cord paralysis.

Event Description

Additional information was received that the patient's hoarseness has resolved per the ent.However the patient will never be able to speak loudly.Patient's neurologist decided to not replace the vns device as patient has had only one seizure since (b)(6) 2015.

Manufacturer Narrative

Date received by manufacturer (mo/day/yr), corrected data: 10/6/2015.The previous supplemental mdr #9 incorrectly lists the aware date as 08/04/2015.The correct aware date is 10/06/2015.

Manufacturer Narrative

G.4.Date received by manufacturer (mo/day/yr), corrected data: 11/04/2015.The previous supplemental mdr #10 incorrectly lists the alert date as 11/04/2014.The correct aware date is 11/04/2015.

Event Description

Patient reported that he benefitted from vns therapy initially.The lead protruded through the skin the lead and the wire were removed.It was reported that the lead was not on the nerve at the time of having infection.As patient's seizures have increased, patient wanted the left vns implant again.Patient was informed that the left vagus nerve will be explored and the vns will be implanted if the left vagus nerve is healthy.Patient was confirmed to have been re-implanted with vns.

Manufacturer Narrative

G.4.Date received by manufacturer (mo/day/yr), corrected data: 02/07/2017.Previous supplemental report # 12 incorrectly listed the aware date as 08/04/2015 instead of the true aware date of 02/07/2017.

• Brand Name: LEAD MODEL 302
• 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: 4274290
• MDR Text Key: 5359202
• Report Number: 1644487-2014-03106
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2006
• Device Model Number: 302-20
• Device Lot Number: 011406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2004
• 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
• Treatment: NA.
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male