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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

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CYBERONICS, INC. PROGRAMMING WAND Back to Search Results
Model Number 201
Event Date 06/18/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's handheld is giving the physician problems. It was reported that there is no connection with the generator and the handheld. The physician attempted to change the battery and check connections without result. The physician requested a new programming computer. The handheld is expected to be returned for analysis, but has not been received to date.

 
Manufacturer Narrative

 
Event Description

It was reported that the handheld was successfully used to interrogate several patient's devices. It was determined that once the unit was unplugged from the electrical outlet no further issues were observed.

 
Event Description

Additional information was received stating that the programming system was able perform interrogations without any issues after replacing the 9v battery of the programming wand.

 
Manufacturer Narrative

Brand name; corrected data: additional information indicates that the suspect device is the programming wand. Type of device, name; corrected data: additional information indicates that the suspect device is the programming wand. Model #, serial #, lot#, other; corrected data: additional information indicates that the suspect device is the programming wand. Device manufacture date; corrected data: additional information indicates that the suspect device is the programming wand.

 
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Brand NamePROGRAMMING WAND
Type of DevicePROGRAMMING WAND
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 Key3936485
Report Number1644487-2014-01786
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/18/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/15/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number201
Device LOT Number1063528
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/07/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/12/2010
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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