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

Model Number 105

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

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

Event Date 09/15/2017

Event Type  malfunction  

Event Description

Report received that fluid was found in the generator header.A patient had been receiving a lead revision due to low impedance.Low impedance was reported in mfr.Report #1644487-2017-04471.While replacing the lead, the septum plug on the generator was unintentionally removed.This required the generator to be explanted.Upon explant, fluid was found in the generator header.The generator was replaced.A device history performed on the generator showed all quality inspections were performed and passed prior to release for distribution.The generator has not been received by the manufacturer to date.No further relevant information has been received to date.

Event Description

Further information was received that the fluid found in the generator header was due to the detachment of the silicone tubing reported in mfr.Report #1644487-2017-04471.There was no generator malfunction that caused the fluid to enter the generator header.The generator was received by the manufacturer but product analysis has not been completed to date.No further relevant information has been obtained.

Event Description

Product analysis was completed on the generator.Visual examination was performed, and besides typical marks and discoloration associated with explant, no anomalies were found.The septum plug was not returned.No bodily fluid remnants were observed in the header septum cavity.Both an interrogation and system diagnostic test were performed.Lead impedance and current delivered were normal for all tests performed.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The septum cavity size was within specification requirements.There were no performance or any other type of adverse conditions found with the pulse generator.The downloaded data from the generator was also reviewed.An auto-measurement was performed and provided the battery voltage and estimated charge consumed.The values were normal.No further relevant information has been provided to date.

• 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: 6874741
• MDR Text Key: 86746004
• Report Number: 1644487-2017-04472
• 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,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/11/2019
• Device Model Number: 105
• Device Lot Number: 204101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• 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: 10 YR