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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
Event Date 09/17/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a vns patient is having vocal cord paralysis. The paralysis began after the patient underwent a full vns system replacement surgery. Information was received that the patient was implanted on the right vagus nerve. Review of manufacturing records confirmed all tests passed for the concerned generator prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Follow up information received that the patient has been implanted on right vagus nerve because it was impossible to find a place to attach the electrode on the left side when the previous lead had been removed. This was due to adherences on the vagus nerve. The generator has been implanted on the right side as well. Both right and left vocal cords are paralyzed and physician believes this is definitely related to vns surgery. The left vocal cord was completely paralyzed, the right vocal cord partially paralyzed. The implanted generator has never been programmed on. No diagnostic test results available. The patient has had tracheostomy and still has his tracheostomy with a tracheal cannula in place.

 
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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 Key6066750
Report Number1644487-2016-02520
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/07/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/31/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/17/2017
Device MODEL Number106
Device LOT Number4536
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/30/2015
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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