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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 Date 08/29/2011
Event Type  Injury  
Event Description

Reporter indicated a vns patient was hospitalized due to difficulty breathing with stridor, asthma, and vocal cord paralysis. The vns was disabled and the patient improved. The patient is being treated with medication. The patient had recently had the vns generator replaced on (b)(6) 2011. The patient was originally implanted with vns on (b)(6) 2007. Attempts for further information are in progress.

 
Manufacturer Narrative

 
Event Description

Reporter indicated he would not provide any information to the manufacturer regarding any patient events.

 
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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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2265822
Report Number1644487-2011-02284
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/31/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/30/2011
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: 09/27/2011 Patient Sequence Number: 1
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