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

Model Number 106

Device Problem Detachment Of Device Component

Event Date 03/08/2017

Event Type  Malfunction  

Event Description

It was reported that the septum plug fell out when the surgeon when he took it out to insert the lead. The generator was not used and the patient was implanted with a different generator. The suspect device was received and was returned due to "faulty generator/loose screw. " analysis is underway but has not been completed to date. A review of device history records for the generator shows that no unresolved non-conformances were found.

Manufacturer Narrative

(b)(4).

Event Description

Analysis was performed on the returned generator and showed that the pulse generator performed according to functional specifications. Detachment of the septum plug was observed ¿as received¿ prior to decontamination, which may possibly be implant-related damage. The returned setscrew shows mechanical wear on the socket (suggesting numerous insertion attempts) and septum debris is in the socket (verifies the setscrew was extracted up into the septum). In addition, the returned septum shows damage on the underneath side, which indicates the setscrew was extracted up into the septum, which may have been the contributing factor for the detachment of the septum plug. The header septum cavity and returned septum meets specification requirements. Other than the noted septum plug detachment, 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: 6453706
• Report Number: 1644487-2017-03535
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH
• Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/03/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 08/31/2018
• Device MODEL Number: 106
• Device LOT Number: 203928
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: Other
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial