MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Pain (1994); Seizures (2063)

Event Date 12/17/2004

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that the patient never tolerated high vns settings and experienced coughing, gagging and painful stimulation in the throat when stimulation was higher than 0.5ma.On (b)(6) 2014, the vns was near end of service.As patient only had few seizures per year, the output current was disabled but magnet was left on.No diagnostics were able to be performed successfully due to patient's low vns settings and intolerability to high settings.Additional information was received that the patient underwent explant surgery on (b)(6) 2016.The explanted device(s) were not received to date.

Event Description

Additional information was received that the surgery was due to device reaching end of service and family request to remove the device.The surgery was for patient comfort and not to preclude a serious injury.Patient was never able to tolerate advancement to therapeutic levels on vns device due to significant coughing.

• Brand Name: PULSE GEN MODEL 102R
• 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: 5869272
• MDR Text Key: 51866773
• Report Number: 1644487-2016-01801
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2005
• Device Model Number: 102R
• Device Lot Number: 009728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2003
• 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: 5 YR