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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 06/01/2010
Event Type  Malfunction  
Event Description

It was initially reported that the pt was scheduled for a head scan (with head coil) mri and was in the scanner for 59 seconds. At the time, the pt's mother had not told scanning technicians about the pt's vns device; consequently, it was not disabled during this brief time period. Once the vns implant was discovered, the scan was stopped. The nurse performed a system diagnostics test, which showed high lead impedance. The pt was known to have her pulse generator placed in the abdominal cavity due to her comorbidities. The pt was disabled and the mri was continued. It was later indicated that the pt had a fall about two weeks prior to the mri, of which the mother was not initially forthcoming about. The pt apparently fell and hit her stomach area, which is the place where the pt has her generator placed due to the many shunts she has in place due to her disease. She indicated that she received a copy of the radiologist's reports and there was a note that there was a lead fracture in the neck area. The x-rays were requested to be sent to the manufacturer for review, but have yet to be received. There was a belief that the fall was the cause of the high impedance and not the mri. A search performed in the manufacturer's programming history database showed that the last known diagnostics were within normal limits. It is unk at this time if the pt will be having the device replaced.

 
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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 Key1774433
Report Number1644487-2010-01715
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/01/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2006
Device MODEL Number302-20
Device LOT Number010539
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/01/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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