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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 Problems Detachment Of Device Component; Mechanical Problem
Event Date 11/02/2017
Event Type  Malfunction  
Event Description

It was reported that during a replacement surgery, the surgeon attempted to screw in the setscrew on the new generator with two separate screwdrivers, but he could not get the screw to click. The septum plug and screw then proceeded to fall out of the generator, so they had to implant a new generator. Reportedly, the set screw was turned in the correct direction, but it would not engage from the very first turn. There was no clicking sound at all and it wouldn¿t hold the lead securely in place. The suspect product was returned but product analysis has not been completed to date. No further relevant information has been received to date.

 
Event Description

Product analysis was completed on the returned generator on. Analysis found that the header septum cavity and the septum met dimensional specifications. Examination of the set screw identified indentation marks at the bottom of the set screw which shows that a lead pin or test resistor was secured with the returned set screw. Furthermore, the hex head was damaged with the hex socket rounded out, which can occur when the torque wrench is not fully engaged into the hex head. This damaged hex head would prevent the tightening of the set screw on the lead pin or the test resistor and may have contributed to the detachment of the set screw. No further anomalies were identified. No further relevant information has been received to date.

 
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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 Key7062442
Report Number1644487-2017-04869
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/14/2019
Device MODEL Number106
Device LOT Number5369
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/15/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/26/2017
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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