MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Dyspnea (1816); Pain (1994)

Event Date 07/21/2015

Event Type  Injury  

Event Description

It was reported that the patient has shortness of breath with stimulation that started last year.She says that the battery is also moving around in her chest and has become painful in the last 6 weeks.The patient was referred for explant of the vns.Clinic notes dated 2/12/2016 were received which indicate that the patient's vns is going off every minute and causes breathing problems.The implant also seems to be moving.The patient's physician did not recommend that the vns be removed.She has turned the output down to 0.25ma and the heartbeat detection off.Diagnostics were last performed on (b)(6) 2015 and showed output=ok/lead impedance=ok/impedance value=3183ohms.No interventions have been planned.No causal or contributory programming or medication changes preceded the onset of the shortness of breath.No patient manipulation or trauma occurred.A non-absorbable suture was used to secure the generator to the fascia during implantation of the device per the surgeon; a 3.0 prolene suture.On (b)(6) 2016 it was reported that the patient's generator would be removed that day.The explanted generator has not been received for product analysis.

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016 it was reported that the explanted device was discarded by the hospital and therefore cannot be returned for product analysis.

• Brand Name: PULSE GEN MODEL 106
• 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: 5513325
• MDR Text Key: 40778467
• Report Number: 1644487-2016-00593
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/02/2017
• Device Model Number: 106
• Device Lot Number: 4405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• 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: 51 YR