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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. BIPOLAR LEAD 300 Back to Search Results
Model Number 300.20
Event Date 07/01/2009
Event Type  Malfunction  
Event Description

It was reported by the surgeon that the patient underwent a full revision surgery due to lead disconnected from nerve. X-rays were taken which clearly showed top lead disconnected from the nerve. X-rays were not available for further manufacturer review. No patient manipulation or trauma was reported. Explanted products were returned to manufacturer for further review. Analysis was completed on the lead and reported allegation of high lead impedance was not confirmed. Condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted.

 
Manufacturer Narrative

"electrode detach from nerve is beyond the scope of activities performed in the product analysis lab". The portion of the lead that was returned for analysis did not reveal any anomalies. However, a device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NameBIPOLAR LEAD 300
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1497730
Report Number1644487-2009-01835
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/28/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2003
Device MODEL Number300.20
Device LOT Number3979
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/30/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/28/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2001
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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