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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 08/01/2015
Event Type  Death  
Manufacturer Narrative

 
Event Description

It was reported that a vns patient was deceased. Follow-up to the patient's long-term group care facility revealed that the cause of death was cardiac arrest. It was reported that in the week prior to the patient's passing the patient indicated abdominal discomfort and was evaluated by the staff. A physical examination on (b)(6) 2015 revealed the patient was alert, hydrated, and not in distress. The patient's lungs were noted to be clear of congestion. An ekg was performed and detected no murmur, no arrhythmia, and indicated normal function. Of the heart the patient was then seen by the treating neurologist on (b)(6) 2015 and the vns was checked. The patient experienced the cardiac arrest on (b)(6) 2015 and was taken to the nearest hospital. It was stated attempts to resuscitate were performed, but were unsuccessful and the patient was pronounced dead at arrival to the hospital. The hospital and the long-term group care facility declined to perform an autopsy. It was reported that as there was no clinical evidence of the underlying cause of cardiac arrest, sudep was possible. No additional relevant information has been received to-date.

 
Event Description

Follow-up to the vns physician at the patient's group home revealed that the patient had died from a sudden cardiopulmonary event. Diagnostics performed on (b)(6) 2015 were within normal limits.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5462820
Report Number1644487-2016-00419
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2015
Device MODEL Number103
Device LOT Number202699
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/09/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/31/2013
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: 02/26/2016 Patient Sequence Number: 1
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