MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Device Inoperable (1663)

Patient Problems Erythema (1840); Pain (1994); Seizures (2063); Swelling (2091); Therapeutic Response, Decreased (2271)

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient had complaints of redness, swelling, and pain at the vns generator site.The physician programmed the vns off and referred the patient back to the ent for evaluation of the site for infection.Additionally information was received which stated the patient also believes the generator is heating and not working.The patient stated he has had an increase in seizures as well as a change in seizure type.Later it was reported the physician does not feel the patient's symptoms were related to vns, but believed it was a "nerve issue".It is unknown what the nerve issue is, or what may have caused the nerve issue to occur.A x-ray assessment was provided by the physician which stated "gross satisfactory vagal nerve stimulator.No acute finding".Attempts for additional relevant information have been unsuccessful to date.

Event Description

Clinic notes were received due to re-implant surgery referral due to a "problem with the vagus nerve stimulator".It was mentioned in the notes that the patient was still having seizures.The patient's replacement occurred on (b)(6) 2016 and it was noted he was switched from a model 105 generator back to a model 102 generator.After the generator was replaced with the new generator, the system diagnostic results confirmed the device was working as intended.It was reported by the physician's office that the patient was last seen on (b)(6) 2016 and had mild pain, redness, and 4 seizures.It was confirmed that these seizures have increased from her baseline.It was noted that an additional event had occurred which lasted for hours and the patient felt heating around the vns device.There was not reason specifically given for the increase in seizures.It was noted that the vns settings on (b)(6) 2016 were at therapeutic levels and the diagnostics were within normal limits.It was noted the device would not be returned per hospital regulations.It was further reported by the company representative who was at the surgery that the m105 was "faulty" and needed to be replaced, or per patient request, would be removed completely.The patient requested to have a 102 as he did not have any issues with the m102.Per the patient and the surgeon, the believed cause of the burning sensation and irritability was due to the 105 generator.According to the patient, the burning sensation occurred immediately after the 105 settings were adjusted, but continued even after the device was programmed off.Attempts for additional information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 5726096
• MDR Text Key: 48420901
• Report Number: 1644487-2016-01354
• 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: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/08/2016
• Device Model Number: 105
• Device Lot Number: 4082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2014
• 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 Age: 53 YR