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

Model Number 102

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

Patient Problems Dyspnea (1816); Paralysis (1997)

Event Date 01/01/2016

Event Type  Injury  

Event Description

The patient reported that she was having difficulty breathing and went to her ent physician to be evaluated.There the ent physician diagnosed her with vocal cord paralysis and considered placing a trach to help these issues.It was unclear if these issues were being associated with vns therapy.Attempts for information from the neurologist who manages the patient's vns found that the patient suffers from numerous other health issues.However the neurologist was going to let the ent physician care for the vocal cord paralysis and difficulty breathing.A review of the internal programming history found that the impedance value of the system was within acceptable limits for most of the implant life however the last recorded test occurred approximately 2 years prior to this report.No additional relevant information has been received to date.

Event Description

Further information was received from the ent physician who reported that the difficulty breathing was not occurring with vns stimulation.He believed that the breathing difficulties were related to the vocal cord paralysis which was occurring on the same side as the vns.The physician was unsure of the etiology of the vocal cord paralysis but he did speculate that it was possible that the vocal cord paralysis was related to the patient's cerebral palsy or it may have been an injury secondary to vns.The physician reported that the patient had undergone a tracheostomy to avoid respiratory distress and to allow the patient to comfortably breath.Information was also received from the neurologist who reported that the difficulty breathing had been ongoing for about a year.Additionally, the neurologist speculated that the vocal cord paralysis and difficulty breathing may be related to vns however it was not clear in what way; either stimulation or vns implant surgery.The neurologist did report that he felt the tracheostomy would help reduce the patient's risk of pneumonia and hypoxia.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 6324827
• MDR Text Key: 67206689
• Report Number: 1644487-2017-03190
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 03/10/2017

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: 03/31/2010
• Device Model Number: 102
• Device Lot Number: 200782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2008
• 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): Other
• Patient Age: 45 YR