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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 05/01/2008
Event Type  Malfunction  
Event Description

It was reported that a vns pt received a high impedance warning during system diagnostic testing. Follow up with the pt's treating vns therapy physician revealed that x-rays of the pt's device were reviewed by the site and that a lead break had been identified during an assessment of the images. The physician indicated that the cause of the event was unk, though the pt was known to "rough play" with his father and siblings. The physician indicated that the pt's chart noted that a high impedance warning had been received a year prior to this report, x-rays were taken and no anomalies were reportedly identified. The pt was scheduled for a full vns revision surgery and during the surgery the implanting surgeon indicated that he pt's lead was found to have evidence of a lead fracture. While attempting to remove the pt's lead, the surgeon reportedly "nicked" the pt's jugular vein prompting the aid of a vascular surgeon for repair. As a result of the incident, the implant of the pt's new vns device could not occur. The product was returned to the mfr and is currently awaiting analysis.

 
Manufacturer Narrative

Treating medical facility reviewed x-rays of implanted device. Review of x-rays by the treating medical facility revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.

 
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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 Key1438437
Report Number1644487-2009-00435
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/18/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2004
Device MODEL Number302-20
Device LOT Number7083
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/03/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/18/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/2002
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: 04/10/2009 Patient Sequence Number: 1
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