MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNK; GENERATOR

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

Patient Problem Dyspnea (1816)

Event Date 07/13/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

On (b)(6) 2015 it was reported that the patient's vns is scheduled for removal on (b)(6) 2015.The patient was bothered by stimulation and had device turned off in (b)(6) 2015.It was noted that the patient's depression has not worsened and he is having good results with ect.The nurse reported that the patient's vns had been disabled on (b)(6) 2015 and is scheduled to be explanted due to dysphonia and dyspnea.She also reported that the patient's vns had been implanted on (b)(6) 2013 and that the patient's (b)(6).The patient underwent explant of the vns on (b)(6) 2015 but the product cannot be returned for product analysis as the site discards explants.Good faith attempts for further information from the physician were unsuccessful.Attempts were also made for the patient's product information but no further information was received.

Event Description

Clinic notes dated (b)(6) 2016 indicate that the patient is considering replacement of the vns device as she is now having more frequent seizures without the vns.Although surgery is likely, it has not occurred to date.

Manufacturer Narrative

Describe event or problem: if explanted, give date (mo/day/yr), corrected data: inadvertently did not include this information on follow-up report #1.

Event Description

Clinic notes dated (b)(6) 2016 indicate that the patient's vns was disabled several months prior and that the patient is considering replacement of the vns device.Therefore, the patient has not yet undergone explant of the vns system.

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• 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: 5297223
• MDR Text Key: 33482333
• Report Number: 1644487-2015-06743
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2015

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/18/2016; 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 55 YR