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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 01/01/2011
Event Type  Injury  
Event Description

On (b)(6) 2011, it was reported by a vns treating physician that the vns pt was experiencing some scarring around the lead and was being referred for a full revision surgery. The pt was not presenting with high impedance. The physician reported that the scarring started in (b)(6) 2011. The pt feels some pulling and it hurts him when he turns his head to the right; it feels like a pinch. The scarring is around the lead body and electrodes he is scheduled for surgery for scar revision (b)(6) 2011. Interventions are being taken for comfort and to hopefully prevent any injury that could occur because of the excessive scar tissue. The physician reported that there wasn't anything that happened that would have contributed to this condition. The physician provided clinic notes dated (b)(6) 2011 that state that the pt complains about pain and is tugging at the vns lead site on his left neck. He mentions the pain at least once per day. The pt has some scar tissue on his left neck. The pt's programmed settings are 1. 25/30/500/30/3/1. 5/60/500 with a systems test and a normal mode test reading ok/lead impedance = ok/dcdc = 2/ eri=no. When additional info is received, it will be reported.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2088584
Report Number1644487-2011-00982
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/13/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2008
Device MODEL Number302-20
Device LOT Number1028
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/13/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2005
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: 05/06/2011 Patient Sequence Number: 1
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