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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

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CYBERONICS INC LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 05/22/2009
Event Type  Injury  
Event Description

It was reported that the patient has been experiencing pain from her neck to her hand that began approximately one month following generator and lead replacement six years prior. The pain began with swelling in the patient's neck, shoulder, and arm, and the patient believes that a nerve was pinched at that time. The patient has been on pain medications and has undergone physical therapy and nerve blocks due to the pain. The patient believes that the vns lead electrodes may have been placed incorrectly and that the placement may be putting pressure on another nerve. The patient indicated that the pain occurs with device stimulation because the pain was exacerbated when the device settings were increased in (b)(6) 2014. The patient reported that the device was programmed off for a while and that the pain subsided a great deal. The device was programmed back on in (b)(6) 2015 and the pain began again in (b)(6) 2015. The physician's office reported that the patient has been seen recently and has not reported these events. The physician's office indicated that the patient would be contacted regarding the reported pain. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key4909657
Report Number1644487-2015-05136
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial
Report Date 06/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2011
Device MODEL Number302-20
Device LOT Number2164
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/17/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/21/2008
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: 07/13/2015 Patient Sequence Number: 1
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