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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 03/04/2015
Event Type  Malfunction  
Event Description

It was reported that the physician's tablet was giving a "failure to open port" message. It was mentioned that the usb serial connector on the programmer was "really loose" and they felt that was likely the issue. A new usb serial cable was requested and sent but this did not fix the issue, therefore the issue was believed to be due to the tablet. Attempts have been made for the return of the tablet but it has not been received for product analysis to date.

 
Event Description

Analysis of the tablet was completed on 04/28/2015. The tablet was returned for a reported mechanical problem, serial adapter/cord failure. An analysis was performed on the returned tablet and the reported allegation was verified. The cause for the anomaly is associated with a broken wire connection in the serial cable db9 hood assembly. Once the wire was soldered on to the pcb, no further anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.

 
Manufacturer Narrative

 
Manufacturer Narrative

Device malfunction caused event but did not cause or contribute to a death or serious injury.

 
Event Description

On (b)(6) 2015 the programming tablet and usb cable were received for product analysis. Product analysis is still underway and has not yet been completed.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING COMPUTER
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 Key4628497
Report Number1644487-2015-04224
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 03/04/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/24/2015
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 10.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/01/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/28/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/16/2014
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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