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

Model Number 106

Device Problem Detachment Of Device Component (1104)

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

Event Date 08/29/2017

Event Type  malfunction  

Event Description

During a lead revision surgery, the setscrew came out of the generator, and therefore the generator was replaced as well.A review of device history records for the generator shows that no unresolved non-conformances were found.Additional information was received reporting that the doctor barely unscrewed the set screw and the screw backed out.No other relevant information has been received to date.

Event Description

The product has been received by the manufacturer and analysis is underway but has not been completed to date.No additional relevant information has been provided to date.

Event Description

The generator underwent product analysis.The device was monitored and showed no signs of variation in the output signal.The pulse generator diagnostics were as expected for the programmed parameters.The detachment of the set screw, was observed when the product was received.The returned set screw shows mechanical wear on the socket, suggesting numerous insertion attempts.In addition, the underneath side of the returned set screw shows indention marks, suggesting a lead pin or an in-line test resistor was once secured by the set screw.The returned septum shows damage on the underneath side, which suggest the returned set screw was extracted up into the returned septum, which may have been the contributing factor for the detachment of components.There were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 6857562
• MDR Text Key: 85755925
• Report Number: 1644487-2017-04441
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/27/2018
• Device Model Number: 106
• Device Lot Number: 4921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• 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: 49 YR