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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Detachment Of Device Component
Event Date 10/18/2017
Event Type  Malfunction  
Event Description

It was reported that during the implant surgery for a patient, the torque wrench got stuck in the generator. While trying to remove the torque wrench the set screw came out with the wrench. A new generator was used and the surgery was completed. The generator that was not used was returned to the manufacturer however product analysis has not been completed to date. No additional relevant information has been received to date.

 
Event Description

Product analysis was completed on the returned generator. The septum plug and set screw that fell out of the generator were not returned to the manufacturer for analysis. The header septum cavity measured 0. 125 inches which met specifications. A set screw was inserted into the negative connector block and secured a bench lead with no issues. A comprehensive automated electrical evaluation showed that the device performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Manufacturer Narrative

Unique identifier (udi) # - corrected information: the udi number on the initial report submitted should have been (b)(4).

 
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Brand NameGEN 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 Key7023776
Report Number1644487-2017-04765
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/14/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/16/2019
Device MODEL Number106
Device LOT Number5386
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/02/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/14/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/08/2017
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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