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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
Event Date 11/23/2014
Event Type  Malfunction  
Event Description

Additional information was received that the patient's device diagnostics were checked on (b)(6) 2015 and that the results were within normal limits. It was also reported that the patient's pain was slightly better.

 
Event Description

It was reported that, for the past 1. 5 months, the patient has had random episodes of sudden discomfort from the generator site up to the left side of his neck that is progressively worsening and occurs 5 times per day. The nurse practitioner has adjusted vns but the discomfort doesn't seem to reduce and might not be associated with the stimulation. The patient experiences discomfort when he is lying still, sitting, or standing, doesn't seem to have any trigger. Patient was contacted several times to visit the clinic to adjust vns or disable vns if needed. But patient has not been able to visit due to transportation issues. Patient was last seen in (b)(6) 2014 and patient was set to comfortable settings at that time. No issues were reported with the device during this visit. Patient has been provided with medications for the pain meanwhile. X-rays were received with a note stating that the patient has been complaining of severe neck pain that radiates into his left clavicle. The pain was reported to be independent of vns activation and he does have pain when he turns his head. Per the nurse practitioner, there is a possible mircrofracture of the lead and the vns was disabled. The patient¿s next appointment is on (b)(6) 2015. The x-rays were reviewed and there did not appear to be any lead discontinuities in the portion of the lead that could be visualized. It was noted that the strain relief bend did not appear to be present. The lack of strain relief bend could possibly be a factor in the patient¿s pain. However no conclusions can be drawn regarding the exact cause of the pain. Attempts made for the diagnostic test results were unsuccessful to date.

 
Event Description

Additional information was received that the patient is still experiencing ¿pulling¿ sensation and discomfort in his left neck area. The device is currently off.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

 
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Brand NameLEAD MODEL 304
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 Key4639353
Report Number1644487-2015-04280
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup
Report Date 02/26/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2018
Device MODEL Number304-30
Device LOT Number202926
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received05/18/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/09/2014
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: 03/27/2015 Patient Sequence Number: 1
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