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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. 106 GENERATOR

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CYBERONICS, INC. 106 GENERATOR Back to Search Results
Model Number 106
Event Date 03/02/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported by the patient that the area where her generator was implanted was still sore. The patient was instructed to call her physician. Later, the patient called back and stated her incision had opened up and she was having some yellow and green drainage from the site. At this point, she was once again instructed to contact her physician. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was later reported by the physician that there was no infection at the site of the dehiscence. It was also explained that steri strips were put over the wound an held well, but the patient accidentally pulled the stari strips off, which allowed for the extrusion/dehiscence. Additionally, there were no issues with the device as the diagnostics showed the device was working as intended. The physician also clarified that the pain experienced by the patient was postsurgical pain and was not related to vns.

 
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Brand Name106
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 Key5532604
Report Number1644487-2016-00661
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 03/01/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/06/2017
Device MODEL Number106
Device LOT Number203634
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/02/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/29/2016 Patient Sequence Number: 1
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