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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 02/28/2017
Event Type  Death  
Event Description

It was reported that the patient died in seizure at a hospital. No further relevant information has been received to date. The suspect product has not been received to date.

 
Event Description

The patient's autopsy report indicated that the patient had went to the hospital complaining of lower back pain in the left lower back and urine retention, found to be caused by a kidney stone. This was treated with a foley catheter. After a day, patient had a seizure while he was eating. He had persistent aspiration after the seizure and was later pronounced dead. The patient's autopsy showed food aspiration in the tracheobronchial tree and in the alveoli with foci pneumonitis, the latter probably due to previous small aspirations. There were associated areas of pulmonary edema and parenchymal hemorrhages. Cause of death was determined to be due to respiratory failure secondary to food aspiration during a seizure attack. No further relevant information has been received to date.

 
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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 Key6434921
Report Number1644487-2017-03471
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2017
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/07/2015
Device MODEL Number103
Device LOT Number202518
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/17/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/03/2013
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: 03/26/2017 Patient Sequence Number: 1
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