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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 08/02/2012
Event Type  Malfunction  
Event Description

It was initially reported on (b)(6) 2012 that the physician's ac power cord for the dell x50 handheld computer was damaged due to somebody inadvertently slamming the cord in a drawer. It became frayed and exposed, so they requested a replacement ac power cord/adapter. The company representative confirmed that the damage was due to the site's handling and they were not alleging a device malfunction. A replacement was provided, but later on (b)(6) 2012, it was reported that the computer would not charge. It was initially thought it was a power cord issue, however even with the power cord, the handheld would not charge and thus the battery was depleted. A replacement handheld computer was provided to the site, and the troubled computer was returned to the manufacturer for product analysis. No mishandling was suspected, and the programming system is stored at room temperature in the provided nylon sack plugged into the ac power outlet. Product analysis has not been completed to date on the returned computer and related software. It was noted upon receiving that the battery was inserted backwards into the computer.

 
Manufacturer Narrative

 
Manufacturer Narrative

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

 
Event Description

Product analysis was completed for both the handheld computer and related software. The ac adapter was not returned for analysis. During the analysis it was identified that handheld was unable to charge the main battery. The cause for the anomaly is associated with broken solder connections on the handheld main board. Also during the analysis it was identified that the main battery was inserted backwards. This anomaly can also prevent the handheld from charging the main battery. No further anomalies were identified. 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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2746945
Report Number1644487-2012-02350
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/23/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/17/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number840144
OTHER Device ID NumberMODEL 250
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/20/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/10/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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