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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 06/13/2017
Event Type  Malfunction  
Event Description

During a new patient implant, the surgeon backed the setscrew all the way out and it could not be put back in. The surgeon used a new generator for the surgery. The suspect generator was received and analysis is underway.

 
Event Description

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. The ¿detachment of component(s) septum plug¿, was observed ¿as received¿ prior to decontamination, the septum was inserted up-side down in the header septum cavity, which may possibly be implant-related. In addition, the returned set screw shows mechanical wear on the socket, suggesting numerous insertion attempts. Furthermore, the returned septum shows what appear to be tears in the body of the septum, suggesting that the torque wrench was pushed into the septum, which may have been the contributing factor for the detachment of septum plug. 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 Key6695459
Report Number1644487-2017-04117
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/03/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/15/2019
Device MODEL Number106
Device LOT Number204057
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/26/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/13/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/21/2017
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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