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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

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CYBERONICS, INC. PROGRAMMING WAND Back to Search Results
Model Number 201
Event Date 09/04/2008
Event Type  Malfunction  
Event Description

It was reported that a vns patient came to the office and communication difficulties were experienced during a programming session. The physician was trying to program the generator back to the patient's intended settings but was unable to do so (refer to mfg report no. 1644487-2008-02389 for the programming anomaly event). Troubleshooting was performed which resolved the issue after several tries. When the physician tried to perform diagnostics on the patient's device, the error message "generator failed to respond to initial programming" appeared several times. Good faith attempts to obtain additional info regarding this reported event are underway.

 
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Brand NamePROGRAMMING WAND
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd. ste 600
houston , TX 77058
2812287200
MDR Report Key1188724
Report Number1644487-2008-02369
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/04/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/02/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number201
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/04/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2005
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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