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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 09/07/2007
Event Type  Malfunction  
Event Description

The reporter indicated the pt was admitted to cardiac care unit for monitoring. The pt experienced an asystole and bradycardia, approx five or six mos ago. The pt was seen for video monitoring for his seizures. During the monitoring, the reporter noted that "the pt would go into "true persistent asystole with no pulse. " in addition, the pt had an asystole only during a magnet swipe which was set for 60 seconds on. The reporter stated the pt's magnet output current was set to 3. 5 ma. The reporter indicated the normal stimulation was set to 1. 5 ma. The reporter stated "the pt was having a seizure and they swiped the device initiating a magnet mode stimulation. " the reporter noted the asystole was longer, than when they swiped the pt without a seizure. The reporter stated "the asystole and bradycardia are directly related to vns stimulation. " during the pt's admission in the ccu, the reporter lowered the magnet output current to see how the pt would respond to the new settings. The reporter stated the pt was set to 2. 25ma. Thus, the pt no longer had asystole, but bradycardia. The reporter states "this setting does not help the pt's seizures to abort, but the cardiologist was fine with the bradycardia. " the reporter stated "the pt is fine now, just not getting as good of seizure control with the new setting. " good faith attempts to obtain additional info are in progress and awaiting results.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section F)
CYBERONICS, INC.
houston TX
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste 600
houston , TX 77058
(281) 228 -7200
Device Event Key1008290
MDR Report Key1009251
Event Key887768
Report Number1644487-2008-00640
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/08/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/07/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date08/31/2005
Device MODEL Number102
Device LOT Number009405
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received02/08/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2003
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

Patient TREATMENT DATA
Date Received: 03/07/2008 Patient Sequence Number: 1
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