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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 01/06/2013
Event Type  Death  
Event Description

On (b)(6) 2013, it was reported that the vns patient has passed away on (b)(6) 2013. It was also reported that the physician does not know anything yet about the cause of death and are waiting for the autopsy to be performed which will take time. It was stated that when they have more information they will provide it to the manufacturer. The patient was only implanted with a vns lead at the time of death as the generator had been previously explanted on (b)(6) 2012, due to the wound not closing, extrusion, and possible infection (reported on mfr. Report # 1644487-2012-03036). The surgeon believed that the patient had been picking at the site causing the problem with the wound healing. The patient's obituary was found online which indicated that the patient had passed away in the hospital. A sudep evaluation was performed by the manufacturer with the information available and it was determined to be a possible sudep at this time.

 
Manufacturer Narrative

 
Event Description

Additional information was received on (b)(6) 2013 when it was reported that the manufacturer of the patient's medical device is not eligible to obtain a copy of the patient's death certificate in the state the patient passed away in according to their department of vital records.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key2935007
Report Number1644487-2013-00234
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/07/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2016
Device MODEL Number304-20
Device LOT Number3322
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/21/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/30/2012
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: 01/30/2013 Patient Sequence Number: 1
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