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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK Back to Search Results
Event Type  Injury  
Event Description

It was reported that a vns patient had often complained about hoarseness and discomfort when he would receive stimulation. Recently the patient was hospitalized and the battery in his device was replaced. He now states that he doesn't feel the discomfort/effects from the treatment nearly as much. No information has been received to indicate whether their surgery was to preclude a serious injury or not. Information provided from investigation with the reporter did not indicate answers to the questions asked. No patient information has been provided. Only information provided is as follows. "the effects before the change of device were not at all unbearable for the patient and all is resolved now. ".

 
Event Description

Additional information was attained that this patient's treating physician seemed to attribute the patient's lessened adverse events to improvements in our batteries in the last few years. The patient does well with their depression with the vns.

 
Manufacturer Narrative

Patient implanted for depression.

 
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Brand NamePULSE GEN MODEL UNK
Type of DevicePULSE GEN MODEL UNK
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2993139
Report Number1644487-2013-00629
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/13/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/07/2013
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 Received02/28/2013
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

Patient TREATMENT DATA
Date Received: 03/07/2013 Patient Sequence Number: 1
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