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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 10/31/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's programming system was unable to interrogate the patient's generator. It was reported that the wand battery was depleted, but there was no backup battery available. The patient left the office without being interrogated. Further follow-up revealed that the issues with the programming system resolved with wand battery replacement. The patient has not been seen again to see if the device is able to be interrogated. No additional relevant information has been received to date.

 
Manufacturer Narrative

 
Manufacturer Narrative

 
Event Description

It was known that the failure to interrogate was associated with a depleted 9v battery in the programming wand. Although it was not confirmed that the generator was successfully interrogated, it was known that the wand battery was depleted when the patient's device was checked. It is not expected that the programming system could communicate with a dead 9v wand battery.

 
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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 Key4281667
Report Number1644487-2014-03165
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/26/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2016
Device MODEL Number201
Device LOT Number203083
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/20/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2001
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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