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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/18/2015
Event Type  Death  
Manufacturer Narrative

 
Event Description

It was reported that a patient passed away in the hospital due to an unknown reason. The patient's device was not explanted. Programming history showed that the device was functioning properly approximately two weeks prior to the death. No further relevant information has been received to date.

 
Event Description

The records from the patient's hospitalization and subsequent death were received. The patient presented in the emergency department with cardiac arrest. The patient had a history of chronic heart failure, tracheostomy, and a g-tube. An x-ray of the chest was performed, and there was total opacification of the right lung and lower left lung, which could have been due to pneumonia, effusion, or post-obstructive atelectasis. Labs were performed, and the results indicated hyperkalemia, acute renal failure, and metabolic acidosis. The official cause of death was primarily hyperkalemia and secondarily acute renal failure, anemia, cardiac arrest, metabolic acidosis, respiratory acidosis, respiratory failure, and septic shock. The death was not attributed to the patient's vns in any way.

 
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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 Key6342620
Report Number1644487-2017-03228
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial,Followup
Report Date 03/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/19/2017
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2014
Device MODEL Number103
Device LOT Number202226
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/14/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/06/2012
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: 02/19/2017 Patient Sequence Number: 1
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