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

Device Problems Therapy Delivered to Incorrect Body Area (1508); Unexpected Therapeutic Results (1631)

Patient Problems Emotional Changes (1831); Undesired Nerve Stimulation (1980); Respiratory Distress (2045); Seizures, Grand-Mal (2168); Depression (2361); Neck Pain (2433); Low Oxygen Saturation (2477)

Event Type  malfunction  

Event Description

It was reported by a patient that he had experienced "irregular stimulation" and painful stimulation with his vns device.The patient reported that the generator (unknown when implanted and reportedly explanted in (b)(6) 2016) caused him to have painful stimulation in the left neck and armpit, and the "irregular stimulation" to his vagus nerve caused his body to "forget how to breathe" while sleeping.The patient also reported that he had to then start using oxygen at night to make sure his body continues to breathe while he sleeps.Reportedly, the neurologist informed the patient that the irregular stimulation from the generator caused his nerve to become dependent on the stimulation to remember to breathe, so the neurologist continues to suggest that the patient be re-implanted with vns.However, the patient refused to be re-implanted after the third generator was explanted.The patient kept the third generator after explant, and the lead was left implanted.The patient also reported that vns did help reduce his seizures, but he has stress-induced grand mal seizures which were exacerbated by the painful stimulation and distress over having "defective vns devices." he tried to hurt himself as well because of the painful stimulation and distress.No further relevant information has been received to date.

Event Description

The patient reported that his third generator malfunctioned and shocked his jaw and teeth to the point where he had to get dentures.He reported that he could not get the lead removed where he lived due to the damage on his nerve from stimulation.Neither of the patient's previous surgeons were aware of a third generator being implanted.Attempts for further information were unsuccessful to date.

• Brand Name: PULSE GEN MODEL UNKNOWN
• 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: 6031775
• MDR Text Key: 57627071
• Report Number: 1644487-2016-02378
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2016
• 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