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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/01/2008

Event Type  Injury  

Event Description

It was reported that the vns patient¿s device was disabled and later explanted on (b)(6) 2013 due to respiratory issues.The patient previously experienced trauma to the airway and was respiratory issues during stimulation on-times even at low settings.The patient¿s explanted device has not been returned to date.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2009.The patient¿s device was disabled on (b)(6) 2010.

Event Description

Further follow-up revealed that the patient's device was programmed off on (b)(6) 2010 and that after a year with vns disabled the patient decided to pursue explant in the future.The patient first complained of respiratory stridor and shortness of breath symptoms in (b)(6) 2008.The vns was programmed off and an ent evaluation was performed.The patient's respiratory symptoms were better with vns off.The vns was programmed back on in 2009 and the patient required albuterol, prednisone and continued to have problems with shortness of breath.There was questionable asthma of new onset which was always relieved with vns off.Many attempts were made to continue vns and manage with asthma medications, but they did not help the severe shortness of breath attacks.The physician believes the vns stimulation is related to the patient's respiratory issues.The patient underwent a video stroboscopy in 2009, a vocal cord ct scan in 2011, and a diagnostic laryngoscopy under anesthesia and laryngeal emg in 2011.The patient had emergency room visits and trials with vns stimulation off then on then off again.No programming changes, medication changes, or other external factors caused or contributed to the patient's respiratory issues.The physician reported that the patient experienced prolonged intubation for a period prior to vns implant and possible structural problem of post glottis inlet.The physician reported that the patient's depression benefitted from vns therapy so the respiratory problems were tried to manage for years.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4059317
• MDR Text Key: 4733642
• Report Number: 1644487-2014-02201
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/07/2014

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
• Device Expiration Date: 01/31/2010
• Device Model Number: 102
• Device Lot Number: 200742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/20/2014
• Initial Date FDA Received: 09/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2008
• 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: 47 YR