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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 03/04/2015
Event Type  Malfunction  
Event Description

On (b)(6) 2015 it was reported that the physician was having difficulty interrogating the patient's device, it kept giving ¿procedure failed, checksum error" messages. He reported that he had just recently interrogated several other patients without issue. No further information was received as the physician ended the call. Good faith attempts for further information from the physician were unsuccessful.

 
Manufacturer Narrative

(b)(4). The initial mdr inadvertently did not include the udi for the suspect device at the time. The suspect device for the event was updated from the generator to the programming wand in supplemental mdr #01.

 
Event Description

Additional information was received from the physician reporting that the communication issue was related to a depleted 9v wand battery. After 9v wand battery replacement, the programming system now functions.

 
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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 Key4637643
Report Number1644487-2015-04262
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 03/04/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/11/2016
Device MODEL Number201
Device LOT Number4087
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/07/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/10/2014
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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