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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

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CYBERONICS, INC. PROGRAMMING SOFTWARE Back to Search Results
Model Number 250
Device Problem Computer Software Problem
Event Date 01/01/2013
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

Clinic notes were received and it was found within the notes the patient's mother did not feel the vns had done much for the patient. The nurse practitioner explained that the patient had experienced a status epilepticus event about 3 years ago when the patient's vns settings were programmed off. It was explained this occurred due to the wand being moved by the patient while the device was being checked as the patient was being uncooperative.

 
Manufacturer Narrative

Age at time of event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Date of event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.

 
Event Description

The programming history for the patient's vns generator was reviewed which did not show any points in time where the patient's device was programmed off. However, there are gaps in the available history, so an exact event date could not be determined.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
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 Key6302609
Report Number1644487-2017-03139
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/09/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/10/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/03/2017 Patient Sequence Number: 1
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