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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 01/01/2013
Event Type  Injury  
Event Description

It was reported that the vns patient underwent surgery on (b)(6) 2013 to explant his generator and lead due to a painful lead pulling sensation on the left side of his neck. The patient¿s device had previously been disabled in (b)(6) 2013 due to lack of efficacy. The painful lead pulling sensation continued with the device disabled. The generator and lead were explanted because the presence of the device was causing the pain and the patient never received efficacy.

 
Event Description

It was reported that the explanted devices are not available for return to the manufacturer for analysis.

 
Event Description

It was reported that clinic notes on (b)(6) 2013 note that device diagnostics were within normal limits. The patient's wife indicated that vns therapy did not help the patient and that the patient's arm was sore near the implant site. The patient requested to have the vns explanted.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key3813078
Report Number1644487-2014-01276
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/21/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2010
Device MODEL Number302-20
Device LOT Number1937
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/25/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/15/2007
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: 05/15/2014 Patient Sequence Number: 1
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