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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2016
Event Type  Injury  
Event Description

It was reported that a patient was experiencing an increase in depression symptoms that began nearly a year prior to the report. The patient's depression was above his pre-vns levels. The device was expected to be functional at the time of the increased depression. No additional relevant information has been provided to date.

 
Event Description

The psychiatrist reported that the patient experienced health challenges, namely, painful leg spasms, that contributed to the patient's increased depression. The leg spasms were not attributed to vns therapy. No additional relevant information has been provided to date.

 
Event Description

The patient underwent generator replacement surgery due to low battery. The explanted device has not been received by the manufacturer to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key6513415
Report Number1644487-2017-03655
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2007
Device MODEL Number102
Device LOT Number014911
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/20/2006
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: 04/21/2017 Patient Sequence Number: 1
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