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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 300-30
Event Date 01/01/2009
Event Type  Malfunction  
Event Description

Reporter indicated that the pt underwent full revision surgery, after having a generator revision surgery approx a month earlier. At the follow-up visit following the initial surgery, high impedance was noted, which prompted the full revision surgery. Once the lead was removed during the full revision surgery, it was noted that there was an abraded opening in the silicone sheath surrounding the lead coils. The surgeon was unsure if this occurred due to pulling when removing the lead or not. A portion of the lead was returned to the manufacturer for analysis. Analysis found a lead fracture in the returned lead portion. Pitting and electro etching were found at the site of the fracture which is evidence that the fracture occurred outside of surgery and that stimulation was present for a period of time while the coils were fractured. The reported abrasion in the silicone sheath was also found in the returned lead portion.

 
Manufacturer Narrative

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

 
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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 Key1424784
Report Number1644487-2009-00664
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/06/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/02/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2003
Device MODEL Number300-30
Device LOT Number2236
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/09/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/06/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2001
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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