MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that a patient was being referred for generator replacement surgery due to an unknown reason.Further clarification was provided stating that the patient was being referred for generator replacement due to the impedance being on the "higher end".The event date provided is the date that the impedance value on the "higher end" was noted.Diagnostics were performed and showed that the impedance values were at higher values, but not values considered high impedance by the manufacturer.After device explant, the implant card was received stating that a full replacement was done and the reason for the lead explant was lead discontinuity and an adverse event.Post-op impedance values were reportedly within normal limits.The lead has been returned to manufacturer, but product analysis has not been completed to date.The implant card received by the manufacturer also indicated that an adverse event occurred which was part of the reason for device explant.No further relevant information has been received to date.

Event Description

It was reported that the patient had a diagnostic run before replacement which showed impedance values within normal limits.The patient had reportedly dropped a weight on his chest and was experiencing painful stimulation in his chest after that occurred at output currents greater than 1ma.High impedance was reportedly never found.The explanted lead and generator were returned for product analysis.The explanted lead was returned in 1 piece and product analysis was completed on 07/25/2016.The connector pin contained two sets of screw marks providing evidence that proper contact between the setscrew and connector pin existed at least once.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.The explanted generator was analyzed and showed that the generator exhibited proper functionality in its ability to provide appropriate programmed output currents.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.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 data from the pulse generator was reviewed and showed that no high impedance instances were identified and the generator battery depleted at normal levels.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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: 5788108
• MDR Text Key: 50187029
• Report Number: 1644487-2016-01556
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2018
• Device Model Number: 304-20
• Device Lot Number: 3858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 27 YR