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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

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CYBERONICS, INC. PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 250
Device Problems Computer Software Problem; Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2012
Event Type  Malfunction  
Event Description

It was reported that on (b)(6) 2016 a vns patient experienced an increase in seizures and a decrease in perception 4 years ago in 2012. She had to escalate back up on levetiracetam though it is unclear if this is making any impact. " the device was stated it was not near end of service. The physician noted specifically that ¿ her current output is not consistent with her set parameters and that after 12 years of stimulation she was past the battery life¿ indicating he believes the battery may currently be depleting. Additional relevant information has not been received to-date.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Generator replacement surgery occurred. The generator was received for analysis and was completed 01/18/2017. The report of low battery was not confirmed. During the analysis, there was no indication from the device that an end of service condition existed. The device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Follow-up from the physician provided that the intended output setting was 1. 25 milliamps, however it was started to be 1. 0 milliamps. The device settings were currently reported to be 1. 5 milliamps. The results of the most recent systems diagnostics were within normal limits. The patient¿s increase in seizures was not worse, but was the same as before she had vns, at 3-4 per week.

 
Event Description

Further follow-up from the physician provided that the current output that was not consistent with the set parameters was observed after an interrogation check. The physician stated that it was believed the battery was near end of life. The that the incorrect output current after interrogation of device settings provides evidence that the cause of the incorrect output current was due to a faulted systems diagnostic test, and may be related to the increase in seizures and decrease in perception experienced by the patient.

 
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Brand NamePROGRAMMING SOFTWARE
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 Key6189981
Report Number1644487-2016-02914
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2005
Device MODEL NumberMODEL 250
Device LOT Number009637
Was Device Available For Evaluation? No
Date Returned to Manufacturer12/28/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/07/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/24/2003
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/20/2016 Patient Sequence Number: 1
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