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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 04/29/2014
Event Type  Malfunction  
Event Description

It was reported that there were battery issues with the handheld device. A hard reset was performed and the handheld device was fully charged; however, the battery issues did not resolve. The handheld device has not been returned to date.

 
Event Description

Additional information was received stating that the handheld device will not be returned to the manufacturer for analysis. A replacement battery is expected to be utilized to resolve the reported issues with the handheld.

 
Manufacturer Narrative

Date of event; corrected data: additional information updated the date of event. Name and address, title, first name, last name, facility name, address, city; corrected data: additional information updated the initial reporter. Occupation; corrected data: additional information updated the initial reporter.

 
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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 Key3888538
Report Number1644487-2014-01561
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/27/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1077507
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/24/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/10/2008
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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