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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 08/28/2013
Event Type  Injury  
Event Description

Additional information was received from the neurologist stating that following replacement surgery, the vns patient had severe difficulty swallowing, nerve damage, laryngeal issues, and aspiration. The patient¿s symptoms were reported to be somewhat better.

 
Manufacturer Narrative

Describe event or problem, corrected data: supplemental manufacturer report #01 inadvertently did not include the additional information received from the neurologist.

 
Event Description

On (b)(6), 2013, the patient's father reported that the patient has been experiencing several adverse events after having his most recent vns replacement on (b)(6), 2013. The adverse events included losing his voice, coughing and choking while he eats, aspiration pneumonia, and a hole in an unspecified location. Attempts for additional information have been made; however, they were unsuccessful. No additional information has been provided.

 
Event Description

The patient was seen for follow-up with the surgeon. The device interrogation was within normal limits. The surgeon indicated that he initially thought the patient's issues were due to the patient being intubated for implant surgery. The surgeon indicated that the patient likely has recurrent left laryngeal polyps which he feels will continue to heal over the next six months. The surgeon offered the patient a follow-up appointment in three months. The surgeon reported that it is reasonable that scar tissue could have been dissected and such outcomes would be reasonable to occur.

 
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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 Key3528864
Report Number1644487-2013-03855
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/22/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2015
Device MODEL Number103
Device LOT Number202553
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/21/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/25/2013
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: 12/19/2013 Patient Sequence Number: 1
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