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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Detachment Of Device Component
Event Date 08/29/2017
Event Type  Malfunction  
Event Description

During a lead revision surgery, the setscrew came out of the generator, and therefore the generator was replaced as well. A review of device history records for the generator shows that no unresolved non-conformances were found. Additional information was received reporting that the doctor barely unscrewed the set screw and the screw backed out. No other relevant information has been received to date.

 
Event Description

The product has been received by the manufacturer and analysis is underway but has not been completed to date. No additional relevant information has been provided to date.

 
Event Description

The generator underwent product analysis. The device was monitored and showed no signs of variation in the output signal. The pulse generator diagnostics were as expected for the programmed parameters. The detachment of the set screw, was observed when the product was received. The returned set screw shows mechanical wear on the socket, suggesting numerous insertion attempts. In addition, the underneath side of the returned set screw shows indention marks, suggesting a lead pin or an in-line test resistor was once secured by the set screw. The returned septum shows damage on the underneath side, which suggest the returned set screw was extracted up into the returned septum, which may have been the contributing factor for the detachment of components. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NamePULSE GEN MODEL 106
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 Key6857562
Report Number1644487-2017-04441
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/27/2018
Device MODEL Number106
Device LOT Number4921
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/25/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/02/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/13/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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