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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 MODEL 250
Event Date 09/22/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient was seen in clinic on (b)(6) 2014 for a vns follow-up visit; system diagnostics were performed and the patient experienced pain at the electrode site with stimulation. No changes were made to the patient¿s device settings during the office visit. The patient reported that when he swipes his magnet, he feels the same pain. The patient returned to the clinic on (b)(6) 2014 and the device magnet current different than what was previously programmed. No further information relevant to the event has been received to date.

 
Manufacturer Narrative

Brand name, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Type of device, name, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Model #, serial #, lot #, expiration date, other, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, these fields are being updated to reflect the suspect medical device. Operator of device, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the user of the suspect medical device. If implanted, give date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. If explanted, give date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Device manufacture date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Labeled for single use, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Usage of device, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4207463
Report Number1644487-2014-02853
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 10/01/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/28/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2005
Device MODEL NumberMODEL 250
Device LOT Number3673
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received01/15/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/24/2001
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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