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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 01/01/2014
Event Type  Malfunction  
Event Description

It was reported that the psychiatrist¿s handheld device was unable to be charged for the last several months. The connection between the handheld device and power adaptor would not stay in place and appeared to be damaged. The handheld device has been returned to the manufacturer where analysis is currently underway.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed that the handheld passed all functional tests prior to distribution.

 
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 mechanical anomalies were identified during the analysis. It was identified that the main battery was unable to hold a charge and power the handheld. The cause for the identified anomaly is associated with a defective battery. No further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. No anomalies associated with flashcard software or databases 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 Key4019040
Report Number1644487-2014-02045
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/18/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number523493
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/30/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/28/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/28/2006
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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