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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 11/02/2014
Event Type  Injury  
Event Description

It was reported that the patient was in the icu due to seizures. It was reported that the patient could no longer feel device stimulation and was wondering if the vns was still working. It was reported that the patient experienced three seizures after the noon hour the day prior and that the magnet would not abort the seizures. Further follow-up revealed that the patient was stable and would be seen by a neurologist to have the device checked. The patient was seen the same day by the neurologist at which time it was reported that device diagnostics were within normal limits and the generator was not at end of service. Attempts to obtain additional relevant information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
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 Key4287528
Report Number1644487-2014-03173
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2013
Device MODEL Number103
Device LOT Number201906
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/03/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/13/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/01/2014 Patient Sequence Number: 1
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