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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 Problem Seizures (2063)
Event Type  malfunction  
Event Description
It was reported that over the last year the patient's generalized tonic clonic and focal seizures had increased.The patient's seizures also weren't responding to the vns magnet as they had previously.The physician believes the increase could be related to the onset of puberty but is also concerned it could be related to the vns device not working properly despite the device seeming to be ok upon interrogation.The patient was referred to the surgeon for consult however there is no information regarding a potential surgery.
 
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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 Key7238219
MDR Text Key99081292
Report Number1644487-2018-00154
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Date Manufacturer Received01/08/2018
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
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