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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING COMPUTER PROGRAMMING SOFTWARE

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CYBERONICS, INC. PROGRAMMING COMPUTER PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 250
Event Date 04/08/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's handheld will not power on and the charge light does not illuminate when the unit is plugged into the ac power cord. A known working power cord was used and the charge light would still not illuminate and the handheld would not power on. The lock button was not engaged. The physician was provided a new programming tablet and the handheld and flashcard were returned for analysis. Analysis of the handheld was completed on (b)(4) 2014. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the handheld would not power on. The cause for the identified anomaly is associated with an open fuse in the handheld. Once the fuse was replaced no anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. The cause for the open fuse is most likely related with an electrical short caused by the damaged record button on the side of the handheld. No other anomalies were identified. Analysis of the flashcard was completed on (b)(4)2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

 
Event Description

Clinic notes were received dated (b)(6) 2014 for the patient. Per the notes, the patient was in to see the physician for a follow up evaluation for seizures. During the visit, the clinic notes stated that the patient's generator was not able to be interrogated due to "technical issues". Through additional investigation, the physician confirmed that these "technical issues" were referring to the reported event of the hand held programming device not being able to power on, which was reported in mfr report # 1644487-2014-01221.

 
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Brand NamePROGRAMMING COMPUTER
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key3800223
Report Number1644487-2014-01221
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/10/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/08/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number879565
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/16/2014
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/28/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/28/2006
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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