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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 303

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CYBERONICS INC LEAD MODEL 303 Back to Search Results
Model Number 303-20
Event Date 08/29/2011
Event Type  Malfunction  
Event Description

Additional information was received that the patient went for a lead revision but it was unable to be completed due to adhesions. The office was unsure if the lead was left connected or not. It is unknown what the plan forward will be.

 
Event Description

It was initially reported that the patient had high impedance on a recent systems diagnostics. It is unknown want interventions will be taken but surgery is likely but has not occurred to date. There was not known trauma or manipulation that would have contributed to the patient's high impedance. X-rays were taken and provided to the manufacturer. X-rays did not show any discontinuities in the lead. There was a suspect issue that one of the electrodes may not be on the nerve as the electrodes did not appear to be aligned with each other. This has not been confirmed and may be due to the patient's anatomy. It was also unable to be confirmed that the pin was fully inserted based on the available images and the image quality of the x-rays. Good faith attempts for more information have been unsuccessful to date.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Analysis of programming history.

 
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Brand NameLEAD MODEL 303
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2260627
Report Number1644487-2011-02242
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/29/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/22/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2014
Device MODEL Number303-20
Device LOT Number2859
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/06/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/02/2010
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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