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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 12/05/2014
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the vns patient was experiencing pain in her neck and chest during stimulation on-times and was constantly sore at areas around the lead. The patient¿s lead was found to be visible in the patient¿s neck where it previously was not visible. The patient¿s device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 3062 ohms). Patient trauma is not believed to have caused or contributed to the high impedance. The physician believed that the issues were related to an end of service condition with the patient¿s device. A battery life calculation using the available programming history showed approximately 7. 4 years until near end of service. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key4397157
Report Number1644487-2015-03563
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 12/10/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date11/30/2011
Device MODEL Number103
Device LOT Number2612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/10/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/22/2010
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: 01/08/2015 Patient Sequence Number: 1
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