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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
Device Problems Computer Software Problem; Energy Output To Patient Tissue Incorrect
Event Date 12/27/2016
Event Type  Malfunction  
Event Description

It was reported via clinic notes that the patient's magnet was swiped several times between (b)(6) 2016, but no activations appear afterwards although the facility staff reported that the patient had seizures since then. They reported that they weren't sure if the magnet was activated, but it was unclear whether the patient did not swipe her magnet during seizures that occurred after (b)(6) 2016 or if the patient's magnet swipes did not activate her generator after that date. No further relevant information has been received to date.

 
Manufacturer Narrative

Software version #: 11. 0. 5.

 
Event Description

The physician reported that the magnet was swiped two times after (b)(6) 2016. The patient was seen on (b)(6) 2016, and the last activations seen were on (b)(6) 2016. The patient did feel magnet stimulation, so the magnet was activating the magnet mode stimulation successfully. The patient had prophylactic generator replacement surgery. The generator was discarded by the hospital.

 
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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 Key6269026
Report Number1644487-2017-03061
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/15/2016
Device MODEL NumberMODEL 250
Device LOT Number4102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/02/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/17/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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