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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 300

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CYBERONICS, INC. LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 01/01/2010
Event Type  Malfunction  
Event Description

It was reported that the pt had full revision surgery due to a lead discontinuity. Prior to surgery, the pt had stated that he did not feel stimulation anymore. High impedance was also found on diagnostics. During surgery, the physician visualized a lead fracture just below the electrodes. The physician feels that the break may have been caused by the pt's constant head movement back and forth. Products have been returned to the manufacturer, but analysis is pending. Attempts for further information have been unsuccessful to date.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

 
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Brand NameLEAD MODEL 300
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1944049
Report Number1644487-2010-02928
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/29/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2002
Device MODEL Number300-20
Device LOT Number335
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/17/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/29/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/01/2000
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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