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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 01/22/2015
Event Type  Malfunction  
Event Description

An analysis was performed on the returned handheld, and the reported allegation was verified. Visual analysis verified that the handheld was returned without a battery cover. As a result, the handheld would not power on. Additionally, it was also identified that the main battery was inserted backwards. As a result, the handheld was unable to be powered using battery power. Once the main battery was inserted correctly, and a known battery cover was installed, the handheld performed according to functional specifications. The flashcard and software performed according to functional specifications.

 
Event Description

It was reported that the physician¿s programming handheld was freezing, and the back battery door was missing. A replacement tablet was provided. The suspect handheld was received by the manufacturer for analysis. The handheld battery was received with the battery backwards, in addition to the battery cover missing. However, the analysis has not 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4519676
Report Number1644487-2015-03857
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/22/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number857134
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/06/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/23/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/08/2008
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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