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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 304

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CYBERONICS INC LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 08/01/2012
Event Type  Injury  
Event Description

It was reported that the patient was experiencing extreme fatigue after having his vns generator replaced on (b)(6) 2012. Per the patient's wife, since vns stimulation was resumed, the patient has been more tired and sleeping longer. Information was later received indicating the patient has had shortness of breath since the replacement and a physician indicated that the patient's o2 levels are lower than normal and have yet to increase to the proper levels. Reportedly there was difficulty intubating the patient during the replacement surgery which may have caused problems with the vocal cords. The patient;s voice was noted as "hoarse and raspy" and there are concerns for the patient's air capacity. It was also noted that around (b)(6) 2012, "some sort of internal stitching began to pop nearly out of the skin. " attempts for additional information have been unsuccessful to date.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS INC
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 Key2766128
Report Number1644487-2012-02472
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 08/30/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2015
Device MODEL Number304-20
Device LOT Number201975
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received08/30/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/29/2011
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: 10/01/2012 Patient Sequence Number: 1
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