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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS VNS

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CYBERONICS VNS Back to Search Results
Event Date 11/27/2013
Event Type  Injury  
Event Description

Patient found unresponsive with heart rate of 16 - was hospitalized and intubated; released after several days; patient noted to have increased seizures for the past few months - seizures are different from prior seizures in that she sometimes just drops to the floor without her usual aura and no post-ictal state. Suspect vns-induced asystole/bradycardia.

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Brand NameVNS
Type of DeviceVNS
Manufacturer (Section D)
MDR Report Key3502109
Report NumberMW5033234
Device Sequence Number1
Product CodeLYJ
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/27/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Is The Reporter A Health Professional? Yes

Date Received: 12/02/2013 Patient Sequence Number: 1