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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 10/22/2014
Event Type  Malfunction  
Event Description

It was reported that the physician's handheld has been working intermittently. It was reported that the serial cable port has become loose. It was reported that the physician has not had a situation where she was unable to interrogate a patient's device; however, it has taken several attempt to successfully interrogate several patient's generators. A new programming tablet was provided to the physician. The handheld is expected to be returned for analysis, but has not been received to date.

 
Event Description

The suspect handheld was returned for analysis. An analysis was performed on the returned handheld and the reported allegation was verified. During the analysis, it was identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on (this condition can also cause the handheld to power off intermittently). Additionally during the analysis, it was identified that the handheld was received with the lock button in the locked position. With the lock button in the locked position, the handheld buttons and touchscreen are unresponsive. No anomalies associated with flashcard software were identified during the flashcard analysis.

 
Manufacturer Narrative

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

 
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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 Key4255875
Report Number1644487-2014-03040
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/17/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/17/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/17/2014
Was Device Evaluated By Manufacturer? Yes
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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