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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-30
Device Problems Inappropriate Shock; Material Protrusion / Extrusion
Event Date 04/01/2015
Event Type  Injury  
Event Description

It was reported that the patient has been feeling 'shocks' in the neck at the electrode area for the last few months. X-rays were taken with no issues noted with the vns device. The vns device was tested by the physician with no issues noted. It was also reported that the patient had surgery on his esophagus on (b)(6) 2015, which has caused a 70 lbs. Weight loss and is causing the generator and lead to protrude. The 'shocks' started sometime after this procedure. It was reported that the pain doesn't happen all the time, but is often, and not with every stimulation. It was reported that the patient had the vns device diagnostics run while the patient was turning his head in multiple directions and there was no change in the impedance value. It was also reported that the 'shocks' stopped when the device was programmed off and the pain only occurs during stimulation. The output current was reduced and the off time was increased on (b)(6) 2015 to try to resolve the pain. The patient stated that the pain decreased but that the pain was still present. The patient was referred for generator replacement. No known surgical interventions have been performed to date.

 
Event Description

It was reported that the patient underwent a full revision surgery on (b)(6) 2015 due to reported pain and shocking sensations. It was reported the surgery was performed for patient comfort. It was also reported that the patient's new vns system was programmed on after surgery and the shocking sensation appeared to have resolved. Neither the lead nor the generator have been received to date.

 
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Brand NameLEAD MODEL 304
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 Key4922369
Report Number1644487-2015-05200
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup
Report Date 06/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2015
Device MODEL Number304-30
Device LOT Number201868
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/29/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/09/2011
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: 07/17/2015 Patient Sequence Number: 1
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