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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 12/03/2014
Event Type  Malfunction  
Event Description

It was reported that the nurse practitioner's handheld will not hold a charge. A new programming tablet was provided to the nurse practitioner. The handheld was received for analysis. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

 
Event Description

Analysis of the returned handheld device and software flashcard was completed. No anomalies associated with the handheld main battery were identified during the analysis. The following anomalies were identified: 1) the battery latch was unlocked, preventing the handheld from turning on; 2) the display image was distorted and the inner display glass was cracked ¿ cause associated with mechanical stress; 3) the touchscreen was unresponsive ¿ cause associated with high impedance in the touchscreen circuitry, 4) the serial cable had an intermittent open connection causing the handheld to lose power intermittently while on ac power ¿ cause associated with mechanical stress. Following replacement with a known good screen, full product functionality was restored. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

 
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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 Key4393758
Report Number1644487-2015-03548
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/10/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/07/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1075663
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/19/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/04/2010
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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