• 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 103 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 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2016
Event Type  Injury  
Event Description

Report was received that a patient had experienced painful stimulation during magnet activation. The magnet output current was reduced and the painful stimulation subsided temporarily. About 7 months later, the patient began feeling painful stimulation on the side of the head and ear with normal and magnet mode stimulation. No adjustments in therapy or trauma occurred prior to the reoccurrence of the painful stimulation. System diagnostics were performed and returned within normal limits. A review of the programing history did not show a presence of high impedance. A review of chest x-rays did not indicate there was any malfunction present. The patient was referred for a generator replacement because adjusting settings did not resolve the painful stimulation and the physician indicated he believed the generator was malfunctioning. No surgical intervention has occurred and no further relevant information has been received to date.

 
Event Description

It was reported that the patient still has left ear pain with stimulation. The setting was decreased to 0. 5 ma but the issue still occurs. A review of additional x-rays received did not indicate any malfunction. No surgical intervention has occurred to date and no further relevant information has been received to date.

 
Event Description

The patient¿s generator was replaced on due to painful stimulation. The explanted generator was received and analysis is underway but has not been completed to date. No additional or relevant information has been received to date.

 
Event Description

Product analysis on the generator model 103 was completed and approved. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿ and ¿painful stimulation¿). In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse 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. There were performance or any other type of adverse conditions found with the pulse generator.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
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 Key6801108
Report Number1644487-2017-04312
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2014
Device MODEL Number103
Device LOT Number202364
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/08/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/01/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/09/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/17/2017 Patient Sequence Number: 1
-
-