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

Model Number 105

Device Problem High impedance (1291)

Patient Problem Pain (1994)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

It was reported that the patient experienced painful device stimulation at the neck every 5 minutes.Device diagnostics were performed which showed high impedance.The patient was referred to surgeon.There was no known trauma that may have caused or contributed to the high impedance.X-rays were performed and the x-ray review was sent to manufacturer.X-rays do not indicate a lead discontinuity.Surgical office notes dated (b)(6) 2015 not that there is a questionable microscopic lead break and new lead and generator are needed.It was noted that the patient's symptoms are worse at work and stop when the patient is home.No known surgical intervention has been performed to date.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

Additional information was received stating that the patient's painful stimulation began occurring about four to five months following (b)(6) 2014 generator replacement surgery.X-ray review by the surgeon reported no conclusive results.The lead pin was stated to be fully inserted during the (b)(6) 2014 surgery, as verified on x-rays, and no lead fracture was visualized.Device diagnostics taken after this (b)(6) 2014 revision were stated to be normal.The surgeon also reported he did not believe the patient's neck pain was related to vns.No known surgical interventions have occurred to date.

Event Description

Additional information was received that the patient underwent a prophylactic generator replacement surgery (b)(6) 2015.The patient's device was seen to have been programmed off prior to surgery.Pre-operative diagnostics were run and showed normal impedance readings.Thus, only the generator was replaced and incomplete lead pin insertion was believed to be the cause of the previous intermittent high impedance result.Complete pin insertion was verified with the surgeon.A system diagnostic test indicated normal impedance upon being run three times.An implant card was received which confirmed the high impedance as the reason for the generator replacement being scheduled.The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

• Brand Name: PULSE GEN MODEL 105
• 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: 4481386
• MDR Text Key: 5348357
• Report Number: 1644487-2015-03743
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2015

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
• Device Expiration Date: 12/31/2015
• Device Model Number: 105
• Device Lot Number: 202808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 02/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/06/2015; 04/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 51 YR