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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER

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CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 250
Event Date 06/22/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported on (b)(6) 2016 that a physician's tablet was not charging with the charger. The company representative used her charger with the physician's tablet, and the tablet charged properly. The company representative was the one to identify that the tablet was not charging. She also tried using a different outlet with the charger, but it did not resolve the issue. The tablet has not been received to date.

 
Event Description

The ac adapter was received on 07/26/2016. Analysis was approved on 08/18/2016. Analysis of the returned ac adapter verified that it was no longer able to power a known good tablet. The cause for the device failure could not be determined during the analysis.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING COMPUTER
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 Key5801596
Report Number1644487-2016-01607
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 06/22/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/18/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
OTHER Device ID NumberVERSION 11.0.5
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/26/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/26/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/05/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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