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

Model Number 304-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the np that the patient is experiencing voice alteration while the device is not stimulating.Patient's voice was normal when vns is stimulating.Patient did undergo a recent full revision surgery where they were likely intubated,.Diagnostically, the output current will be titrated down.The patient will also be told to use the magnet to disable therapy.Per implant card received from surgery on (b)(6) 2016, the impedance was marked ok.Additional information was received that the patient's voice alteration began around (b)(6) 2016.Patient had not experienced voice alteration prior to (b)(6) 2016.The voice alteration did not resolve with decrease in output current settings but vocal symptoms have been slowly improving.Patient's voice is not yet to baseline.The relationship between the voice alteration and vns is unclear as voice improves with stimulation and worsens during off time.The nurse practitioner though that it could possibly be side effect of intubation from recent surgery on (b)(6) 2016.Interventions were taken to preclude a serious injury as opposed to patient comfort additional relevant information has not been received to date.

Event Description

Additional information was received that the patient used to experience voice alteration associated with vns stimulation prior to lead revision surgery but now as reverse voice alteration that occurs during vns off time.The hoarseness was reported to be worse in the afternoon.The nurse practitioner attempted to turn down patient's settings and had patient hold the magnet over the device to temporarily disable it, but neither of these helped alleviate the problem.Diagnostics were all ok.Despite different setting adjustments, patient continued to experience the voice hoarseness and was referred to see an ent physician.Patient underwent laryngoscopy exam and flexible endoscopy and no motion in the left vocal cord was visualized.Patient was diagnosed with paralysis of left vocal cord and larynx.Tone improves when the stimulator is on which is why the voice improves but does not allow adduction.The initial diagnosis is that during this patient's lead revision surgery, the recurrent laryngeal nerve was injured.Patient might need more testing and will be referred for speech therapy to work on adduction strengthening of the right cord in the meantime.The ent physician will plan to see patient in 6 months and then consider vocal cord medicalization to help improve voice quality if paralysis persists.

Manufacturer Narrative

Evaluation codes, method: this information was inadvertently reported incorrectly on the initial mfr.Report.

Event Description

It was later reported the patient had a follow-up visit and it was stated the patient is on a "path to full recover" and that there was clear improvement in the patient's voice when the device was not stimulating.The patient's voice continued to sound better when the vns was providing stimulation.No changes were made to the patient's settings and the patient's family is elated with how much improvement they have seen.

• 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: 5908032
• MDR Text Key: 53275044
• Report Number: 1644487-2016-01935
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2020
• Device Model Number: 304-20
• Device Lot Number: 4788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2016
• 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): Other
• Patient Age: 32 YR