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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. BIPOLAR LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 03/01/2010
Event Type  Malfunction  
Event Description

It was initially reported by the physician that the pt was at their office and when she performed system diagnostics, she got high lead impedance. This was only the second time he had seen the pt in his office. Last time he saw him was in july but did not perform any diagnostics at that time. Pt's device was turned off at that time. Physician did not know if any pt manipulation or trauma had occurred. He stated pt had shown no change in seizure frequency. X-rays were sent to manufacturer for further review. Review of the x-rays showed that the electrodes appeared to be off the nerve which could be contributing to the high lead impedance; however, a lead discontinuity cannot be ruled out in the part of the lead that could not be assessed. Pt's last good diagnostics were obtained in (b)(6) 2007. Additional information received stated that the pt had a full revision surgery. Good faith attempts to obtain explanted products for analysis have been unsuccessful.

 
Manufacturer Narrative

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

 
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Brand NameBIPOLAR LEAD 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 Key1674177
Report Number1644487-2010-01062
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/01/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2002
Device MODEL Number300-20
Device LOT Number1862
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/01/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2001
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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