MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  malfunction  

Event Description

It was reported by a physician that a vns patient had high lead impedance after their initial implant.The patient was at their first dosing appointment.A review of the manufacturing records confirmed the generator met all specifications prior to distribution.An x-ray image was received of the device.The placement of the generator is implanted in the left chest below the clavicle.The pin cannot be visualized past the connector block.Strain relief was not adequate.Two tie-downs appear to be present.No obvious gross lead discontinuities or sharp angles were observed in the visible portion of the lead.The cause of the high impedance was not conclusive based upon the image received.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

The patient had generator replacement surgery.The impedance after the generator was replaced was normal, indicating that the most likely cause of the high impedance was incomplete pin insertion.The explanting facility discards product and was unable to return the device for analysis.No further relevant information has been received to date.

Event Description

The physician reported that the lead pin was not re-inserted into the generator prior to replacing the generator.However, based on the fact that the impedance resolved with generator replacement, the most likely cause of the high impedance was incomplete pin insertion.

• Brand Name: PULSE GEN MODEL 106
• 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: 6675327
• MDR Text Key: 78677070
• Report Number: 1644487-2017-04059
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/21/2018
• Device Model Number: 106
• Device Lot Number: 204000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2017
• 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: 4 YR