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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

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CYBERONICS PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 3000
Device Problems Energy Output To Patient Tissue Incorrect; Improper Device Output
Event Date 11/08/2017
Event Type  Malfunction  
Manufacturer Narrative

Software version 1. 0.

 
Event Description

It was reported that the patient was experiencing painful stimulation that occurred when the magnet was swiped. The patient only started experiencing this pain since the most recent adjustment, made with the m3000 programmer. The patient was told to stop using the magnet, until their settings could be adjusted by the doctor. The patient was seen 3 weeks later to reprogram their generator using an older programming system. The magnet current was reduced to help with tolerability. System diagnostics were run and were within normal limits. The patient felt much better about the settings after this appointment. These events have been determined to be due to software error in the m3000 programmer that causes certain parameters to be incorrectly calculated in m106 generators. These incorrect calculations along with a combination of programmed settings, magnet swipes, and autostimulation may lead to a period of continuous current ramping for part or all of an entire therapy burst. During this ramping, the current can exceed programmed values. This is likely the cause of the patient's reported painful stimulation. To resolve this issue, the patient's settings were reprogrammed to avoid this problem. No further relevant information has been received to date.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS
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 Key7133752
Report Number1644487-2017-05024
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 3000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/27/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/20/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/20/2017 Patient Sequence Number: 1
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