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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 07/21/2014
Event Type  Injury  
Event Description

It was reported that following generator replacement surgery on (b)(6) 2014, the patient began experiencing hypoxia and aspiration. The patient immediately began aspirating following replacement surgery and was taken to the er. In the er, the patient was diagnosed by an ent physician with left vocal cord paralysis which is believed to be due to the replacement surgery, a possible stroke, or an endotracheal tube. The physician stated that the patient¿s symptoms should improve in approximately six months. It was noted that the patient continued to have seizures and that the patient began complaining about stimulation on-times. Attempts for additional relevant information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 104
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 Key4080441
Report Number1644487-2014-02302
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup
Report Date 08/12/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2016
Device MODEL Number104
Device LOT Number202846
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received09/17/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/27/2014
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: 09/11/2014 Patient Sequence Number: 1
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