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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC.PULSE GEN MODEL 101

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CYBERONICS, INC. PULSE GEN MODEL 101   Back to Search Results
Model Number 101
Event Date 03/03/2008
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

Initial reporter called to ask if manufacturer had any info on vns pt's experiencing asystole caused by swiping their magnet or stimulation. It was additionally reported "a pt had a seizure and the nurse swiped with a magnet. Afterwards the pt went into asystole, which lasted several seconds. The pt was in the hospital due to seizures and connected to a monitor so they were able to see it. " the pt's seizure rate was above their pre vns seizure rate and was a change for the pt. No further info has been attained from the site after good faith attempts have been made.

 
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Brand NamePULSE GEN MODEL 101
Manufacturer (Section F)
CYBERONICS, INC.
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste 600
houston , TX 77058
(281) 228 -7200
Device Event Key989849
MDR Report Key1022608
Event Key981279
Report Number1644487-2008-00827
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/05/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date12/31/2001
Device MODEL Number101
Device LOT Number40548C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received03/05/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/14/2000
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

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