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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
Event Date 02/01/2015
Event Type  Malfunction  
Event Description

It was reported that the patient is experiencing an increase in seizures. The physician wants the device checked to see if the battery is at end of service; however, the device has not been checked to date. It was reported that surgery will be scheduled if the device is at end of service and is the cause of the increase in seizures. No known surgical intervention has been performed to date.

 
Event Description

An implant card was received indicating that the vns patient underwent generator replacement surgery on (b)(6) 2015. The explanted device has not been returned to date.

 
Event Description

The explanting facility discarded the explanted device; therefore, no analysis can be performed.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4573617
Report Number1644487-2015-04057
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup
Report Date 02/04/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/05/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2011
Device MODEL Number103
Device LOT Number2318
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received04/21/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/25/2009
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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