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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 304-20
Device Problem Device Dislodged or Dislocated
Event Date 03/09/2015
Event Type  Malfunction  
Event Description

It was reported that the patient is feeling a bulging sensation with stimulation. The vns device was tested and no high impedance was found so the neurologist chose to keep the vns device programmed on. X-rays were taken and it was reported that the electrodes appear dislodged from the nerve. The neurologist believes the electrodes were dislodged because the patient began golfing too soon after surgery. It was also reported that the bulge was not visible from the outside; no protrusion. The patient had lead revision surgery on (b)(6) 2015, the generator was not replaced. After the new lead was implanted and connected to the vns generator, diagnostics were performed and were within acceptable levels. Attempts to obtain additional relevant information have been unsuccessful to date. The explanted generator has not been received to date. It was reported that it was likely discarded by the explanting facility.

 
Event Description

It was verified that the lead was detached from the nerve. It was also reported that the lead revision surgery resolved the bulging sensation that the patient was feeling previous to the revision.

 
Event Description

It was later reported through clinic notes the patient experienced widespread muscle spasms in the neck and face prior replacing the lead.

 
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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 Key4953543
Report Number1644487-2015-05198
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup
Report Date 06/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2018
Device MODEL Number304-20
Device LOT Number203056
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/09/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/25/2014
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: 07/30/2015 Patient Sequence Number: 1
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