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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC BIPOLAR LEAD MODEL 302

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CYBERONICS INC BIPOLAR LEAD MODEL 302 Back to Search Results
Model Number 300-20
Event Date 01/01/2010
Event Type  Malfunction  
Event Description

It was initially reported by the nurse that the pt was referred to them for a battery replacement surgery due to end of service (eos). However, the surgeon performed diagnostics prior to surgery and got high head impedance on normal mode and system mode diagnostics. Pt was then taken into surgery for a full revision but the surgeon ended up not implanting anything since the nurse stated that the surgeon may have nicked the jugular vein which resulted in a lot of bleeding. The surgeon sutured the nick, closed the pt and stated he would implant vns after 6 months. Follow up with the treating physician's nurse revealed that they were not aware about the high lead impedance prior to surgery. Last diagnostics was done in 11/2009 which showed everything working within normal limit. No further info was received.

 
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 302
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1613558
Report Number1644487-2010-00302
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/13/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/12/2010
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? Yes
Date Returned to Manufacturer01/14/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/13/2010
Was Device Evaluated By Manufacturer? No
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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