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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 105 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 05/12/2014
Event Type  Malfunction  
Event Description

It was reported by the patient that her device settings had changed on their own from 5 to 10. It is unclear which device settings she was referring to. The patient was experiencing erratic stimulation, pain with stimulation, coughing and voice alteration. The pain was reported to be unbearable at times. The pain occurred at her electrode site and travelled up the left side of her head and down to her shoulder. No known interventions have occurred to date.

 
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Brand NamePULSE GEN MODEL 105
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 Key3854286
Report Number1644487-2014-01414
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/12/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/06/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2013
Device MODEL Number105
Device LOT Number3213
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received05/12/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/14/2011
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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