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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 01/01/2015
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the patient was experiencing an increase in seizures. The patient's father is concerned that the generator battery is low. The patient was scheduled to see the physician to have the device checked. Attempts to obtain additional relevant information have been unsuccessful to date. It is unknown whether or not the increase is above the patient's pre-vns baseline frequency.

 
Event Description

It was reported on (b)(4) 2015 that the patient underwent prophylactic generator replacement on (b)(6) 2015. It was reported that the generator could not be returned for product analysis as the hospital does not return explanted devices.

 
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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 Key4536741
Report Number1644487-2015-03947
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup
Report Date 01/26/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date07/31/2015
Device MODEL Number103
Device LOT Number202627
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/17/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/20/2013
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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