• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problems Detachment Of Device Component; Fluid Leak
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
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 Key6874741
Report Number1644487-2017-04472
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/13/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/18/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/11/2019
Device MODEL Number105
Device LOT Number204101
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/26/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/26/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/26/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-