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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Device Problem Insufficient Information
Event Date 06/01/2013
Event Type  Malfunction  
Event Description

It was reported that the patient has experienced an increase in seizures since prophylactic generator replacement in (b)(6) 2013. It was reported that until 2012 the patient's maximum seizures were 8 a year and in 2013 the patient experienced 34 seizures and 41 seizures in 2014. Multiple device settings changes were made, but the seizures continued. It was reported that device diagnostics were within normal limits (2006 ohms).

 
Event Description

Attempts to obtain additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

It was reported that the patient's generator showed ifi - yes. The physician was concerned that this was premature. A battery life calculation was performed which showed the ifi condition is an expected event based on device settings.

 
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Brand NamePULSE GEN MODEL 104
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 Key4757441
Report Number1644487-2015-04647
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date05/31/2014
Device MODEL Number104
Device LOT Number3353
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/27/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/14/2012
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: 05/07/2015 Patient Sequence Number: 1
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