MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/31/2017

Event Type  malfunction  

Event Description

It was reported that during the patient¿s surgical case, the septum plug and setscrew popped out of the new intended replacement generator.Prior to this occurrence, diagnostic results of the generator connected to the lead outside the implant pocket were within normal limits.It was at the point, the screwdriver was removed from the setscrew that the septum plug came out.The surgeon tried to put the septum plug back in, but it would not stay in.The setscrew also came out with reportedly little or no manipulation.The generator was not used in the patient¿s implant case.The generator device history record was reviewed by the manufacturer.It was found that all quality tests passed prior to distribution.The unused generator has not been received by the manufacturer to date.No additional pertinent information has been received to date.

Manufacturer Narrative

Corrected data: the initial report inadvertently listed the wrong contact as the initial reporter.

Event Description

The generator was received by the manufacturer for product analysis.Product analysis was completed on the returned generator.Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device.Both interrogation and system diagnostic tests were performed.An electrical load was attached to the pulse generator, and results of diagnostic test demonstrate that accurate resistance measurements were obtained.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery measured 2.995 volts during functional testing and showed an ifi=no condition.The internal device data showed that 1.519% of the battery had been consumed.The microscopic visual assessment of the septum shows no visual anomalies.The visual assessment of the returned set screw shows mechanical wear to the set screw socket, suggesting numerous insertion attempts.The socket was not stripped.The set screw also shows indention marks on the bottom of the set screw, which indicates that a lead pin or test resistor was secured with the returned set screw.Manipulation of the torque wrench may have been the contributing factor for the component detachment.The septum and septum cavity met all dimensional requirements.Besides the observed detached components, there was no evidence of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 105
• 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: 6652810
• MDR Text Key: 77920919
• Report Number: 1644487-2017-04013
• 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
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2018
• Device Model Number: 105
• Device Lot Number: 4851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2016
• 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: 20 YR