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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 10/19/2013
Event Type  Injury  
Event Description

Initially, it was reported that the patient developed a new seizure since generator replacement that was head bobbing. Clinic notes dated (b)(6) 2014 were received indicating that the patient's father would like the vns removed because he feels that the patient's head bobbing was related to vns. It was noted that the vns remains off and no head bobbing episodes have been seen. The patient was referred for surgery. No known surgical intervention has 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 Key4226801
Report Number1644487-2014-02933
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/08/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/05/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2015
Device MODEL Number103
Device LOT Number3682
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/08/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/22/2013
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: 11/05/2014 Patient Sequence Number: 1
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