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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 06/27/2011
Event Type  Injury  
Event Description

Clinic notes were received indicating that the vns patient went to the er and was admitted to the hospital on (b)(6) 2011. The patient had approximately 15 ¿episodes¿ that were different from the patient¿s normal seizure types. The episodes involved the patient chewing his tongue and losing consciousness. The patient was sleepier and more confused during the post ictal period. Since hospitalization, the patient had 1-2 seizures. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

On (b)(6) 2014 it was reported that the patient¿s physician retired and the patient was not seeing the other physician in the practice.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key3942259
Report Number1644487-2014-01822
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/24/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2011
Device MODEL Number103
Device LOT Number2419
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/16/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/28/2009
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: 07/17/2014 Patient Sequence Number: 1
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