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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
Event Date 12/14/2009
Event Type  Malfunction  
Event Description

It was reported to the mfr that the vns pt has been experiencing painful stimulation in the neck area erratically due to unk reason. Info from the treating neurologist revealed the pt had been doing well since implant in (b) (6) 2002. Furthermore, there were no reports of pt trauma or manipulation that could have contributed to the reported event. Moreover, both system and normal mode diagnostics were performed at the time of the event and resulted within normal limits and it was noticed the dcdc converter code was 0. The physician was notified regarding the possibility of a short circuit condition in the pt's lead. No add'l info has been rec'd regarding last known good diagnostics. The pt has been scheduled for full revision surgery. X-rays to evaluate the integrity of the device have not been taken. If present, an intermittent short-circuit could have potentially contributed to the pt's erratic painful stimulation event.

 
Manufacturer Narrative

Device failure is suspected, 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 Key1583750
Report Number1644487-2010-00048
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/14/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/13/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2002
Device MODEL Number300-20
Device LOT Number303
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/14/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2000
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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