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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC BIPOL LEAD MODEL 300

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CYBERONICS INC BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problem Detachment Of Device Component
Event Date 08/10/2009
Event Type  Malfunction  
Event Description

It was reported to mfr that during surgery for generator replacement due to normal end of service, the lead connector boot became detached from the lead pin body. It is unclear the cause of this event. The surgeon was using a hemostat clamp to hold on to the lead while loosening the setscrews to remove the lead pins from the generator header. When the surgeon was trying to remove the positive lead pin, the lead connector boot became detached at the lead pin. The pt subsequently had a full revision where a new lead and generator were implanted. The explanted lead and generator have been returned to manufacturer where analysis is underway.

 
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Brand NameBIPOL 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 Key1496941
Report Number1644487-2009-01918
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/10/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/08/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2003
Device MODEL Number300-20
Device LOT Number3274
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/13/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/10/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/01/2001
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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