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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 12/20/2012
Event Type  Malfunction  
Event Description

Two flashcards were returned on (b)(6) 2013 and analyzed with the handheld. Visual analysis of the handheld verified that five of the flashcard slot pins were bent. The cause of the bent pins is associated with mishandling of the device. Once the pins were straightened, no anomalies associated with the handheld performance were noted. Analysis of the flashcards revealed that the 8. 1 version flashcard had 3 bent pins and as a result of the bent pins, the returned handheld would freeze when the flashcard was inserted. Once the electrical shorts were removed and the pins were repaired, not further anomalies were identified. The 8. 0 version flashcard had no anomalies associated and performed according to functional specifications.

 
Manufacturer Narrative

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

 
Event Description

Reporter indicated that the pins located on the handheld computer were bent and that the flashcard was unable to be inserted. The physician indicated that there was nothing that could have occurred that would have caused the pins to become bent nor were there any accidental attempts to place the flashcard in the handheld backwards. The handheld was returned to device manufacturer for analysis on (b)(6) 2013; however, analysis has not yet been completed to date.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2902159
Report Number1644487-2013-00095
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/08/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1075849
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/04/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/14/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/29/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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