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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)
CYBERONICS
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
Device Operator HEALTH PROFESSIONAL
Is The Reporter A Health Professional? Yes

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