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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
Event Date 04/26/2013
Event Type  Injury  
Event Description

It was reported that the patient was recently hospitalized with aspiration pneumonia. The physician's assistant reported that she wanted to have the device programmed off. It was also reported that the patient's family reported that the patient had difficulty swallowing. The physician indicated that the patient's difficulty swallowing was first observed on (b)(6) 2013 and that the aspiration pneumonia was first observed on (b)(6) 2013. The physician indicated that the patient's parents claim that they have noted a decrease in the patient's appetite since vns implant on (b)(6) 2011. The physician reported that the device was programmed off on (b)(6) 2013 and that the difficulty swallowing has continued; therefore the difficulty swallowing and aspiration pneumonia were not related to device stimulation. The physician noted that there were no causal or contributory programming or medication changes that preceded the onset of the difficulty swallowing or aspiration pneumonia. The physician reported that the patient did not have a history of difficulty swallowing or aspiration pneumonia pre-vns.

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3124944
Report Number1644487-2013-01550
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial
Report Date 04/29/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/22/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/29/2013
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

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