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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient had been losing weight. Caregiver stated that the patient would only want to eat once a day and had lost 30 pounds. Per neurologist, the patient gained 30 pounds in the past 3 years until the most recent vns surgery. After the surgery, the patient lost 30 pounds. Patient does not have any history of eating disorders. The neurologist stopped a medication as it might have contributed to the weight loss but the patient's weight did not increase despite this change. Neurologist also added a new medication to help stop the weight loss but this was not effective. Due to the very close temporal relationship between implant surgery and onset of weight loss, the neurologist believes that there is a causal effect with vns therapy. Vns settings have been significantly reduced to see if that helps increase appetite. A review of device history records for the generator shows that no unresolved non-conformances were found.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8180824
Report Number1644487-2018-02350
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 12/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2019
Device MODEL Number106
Device LOT Number204019
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/09/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/15/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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