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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
Event Date 06/21/2010
Event Type  Malfunction  
Event Description

It was reported that the physician's hp hand held would not hold a charge any longer. This event began recently, and it was noted that the product is stored in the office and is always plugged in while not in use. The physician requested a new hand held to replace the non-working device. The hand held and software flashcard were returned to manufacturer for analysis where there were no anomalies found and both the software and hand held performed according to specifications; however, the ac adapter was not returned for analysis and therefore, the ac adapter is not able to be ruled out as the cause of the issue the site was experiencing. Good faith attempts are underway to obtain the ac adapter cable from the site for analysis.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1786065
Report Number1644487-2010-01775
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/30/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/30/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number521384
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/09/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/30/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2003
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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