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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK; GENERATOR
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CYBERONICS PULSE GEN MODEL UNK; GENERATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Seizures (2063); Loss of consciousness (2418)
Event Date 11/27/2013
Event Type  Injury  
Event Description
A maude event report ((b)(4)) was received indicating that the patient was found unresponsive with a heart rate of 16 bpm.It was reported that the patient was hospitalized and intubated and that the patient was released several days later.It was also noted that the patient has experienced an increase in seizures for the past few months and that the seizures are different than prior seizures.It was reported that the patient no longer experiences her usual aura and no post-ictal state.It was reported that vns induced asystole/bradycardia is suspected.No additional information has been received to date.
 
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Brand Name
PULSE GEN MODEL UNK
Type of Device
GENERATOR
Manufacturer (Section D)
CYBERONICS
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 Key3651797
MDR Text Key4287335
Report Number1644487-2014-00556
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Event Location Other
Date Manufacturer Received01/31/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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