MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 12/28/2016

Event Type  malfunction  

Event Description

A generator was being ready to be implanted when the septum plug was found detached from the generator header block.The physician stated that before tightening the set screw, the septum plug came out.A photo of the generator with the septum plug removed was provided and reviewed.The generator was not implanted in a patient and another generator had to be used.The device history record for the generator was reviewed and verified that the generator had passed all quality inspections prior to release for distribution.The generator has not been received to the manufacturer to date.

Event Description

The generator that was not implanted was received by the manufacturer for product analysis.The product analysis has not been completed to date.

Event Description

Analysis was completed on the returned generator due to the reported septum plug being detached.The returned septum and the septum cavity were both verified to meet all specifications required for their respective components.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The returned setscrew showed mechanical wear at the socket, indicating multiple insertion attempts were made, but the socket was not stripped and the returned torque wrench fully inserted with no issues.Additionally, the underneath side of the returned setscrew showed indentions, suggesting a lead pin or test resistor was once secured by the setscrew.

• Brand Name: PULSE GEN MODEL 103
• 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: 6272529
• MDR Text Key: 65586185
• Report Number: 1644487-2017-03070
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2017

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: 10/14/2017
• Device Model Number: 103
• Device Lot Number: 300374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 01/24/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/27/2017; 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1