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

Model Number 106

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384)

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

Event Date 02/14/2018

Event Type  malfunction  

Event Description

It was reported that the surgeon was unable to tighten the set screw into the generator during an initial implant surgery.It was unknown if the set screw was stripped or if there was another issue.The surgeon eventually applied so much force that the polyethylene header assembly came off the generator can and fell on the floor.The surgeon and company representative were unable to find the set screw as it came out of the header, but it was confirmed that the screw did not fall into the patient.A different generator was then implanted.The device history record of the generator was reviewed, and the device conformed to all functional specifications prior to release.The generator was received, but analysis has not been approved to date.

Event Description

Analysis on the generator was approved.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications.Each of the returned torque wrenches secured a bench setscrew (each torque wrench made audible clicks) onto a bench lead and extracted the bench setscrew with no issues (lab conditions).In addition, review of the data downloaded from the pulse generator revealed diagnostics were performed, and an acceptable impedance value was obtained on the date of surgery.The setscrew and septum were not returned for evaluation.The header septum cavity met specification requirements.There were no performance or any other type of adverse conditions found with the pulse generator.No further relevant information has been received to date.

• 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: 7335839
• MDR Text Key: 102271549
• Report Number: 1644487-2018-00366
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: 106
• Device Lot Number: 204065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• 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: 44 YR